FDA Device Recalls in 2023
569 recalls found
November 2023
Multitom RAX with software version VF10
Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.
Siemens Healthineers sent an Urgent Medical Device Correction letters dated March 20, 2021 to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens Healthineers will issue a software correction (VF11C) that will eliminate both issues. The software solution will be distributed remotely via Update Instructions XP006/21/P.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
Ethicon issued Urgent Medical Device Recall Removal letter on 9/09/20 via email to responsible Johnson & Johnson Affiliates in affected countries who will be contacting all their impacted primary and secondary consignees and/or end customers. The letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall onhand and quarantine such product(s). 2.Remove the product subject to this recall and communicate the issue to relevant operating roomor materials management personnel, or anyone else in your facility who needs to be informed. 3.If any product subject to this recall has been forwarded to another facility, contact that facility toarrange return. Please consider including a copy of this recall letter when communicating. 4.Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice. Customers are required to return unused impacted VICRYL Suture, Product Code V960G, LotPJ5352 subject to this recall that are in their inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than December 1,2020. Any non-affected product and any product returned after the date specified will not receive replacement.
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
An Urgent Field Safety Notice dated 5/17/21 was sent to customers. Actions required to distributors and economic operators 1. Immediately suspend deliveries, identify and quarantine all the devices in your possession which are listed in Annex no. 1 "List of Impacted batches". 2. Share this Field Safety Notice within your organization with all interested parties. If you have distributed the products covered by this FSN to third parties, identify these subjects and forward this letter to them immediately, communicating to each hospital the detailed list of the goods subject to this action that have been supplied by you, using the template of the Annex no. 2 "Letter of the Distributor to Hospitals" Table A1 (making sure to fill in Table A1 with the detail of the article codes and the lots destined for that hospital). 3.Fill in and sign the attached Annex no. 3 "Acknowledgment of the distributor" specifying the quantity of the quarantined goods, including their lot number, their code and inform Adria Srl by sending an email to qa@adriamedical.com and xport@adriamedical.com as soon as possible / within 10 days of receipt of this letter. 4.Adria Srl will contact you to organize the collection of the goods. Adria Srl will replace the goods as soon as possible. Actions required of hospitals and healthcare facilities 1. Identify and immediately stop using the concerned products. Place in quarantine all items listed in Table A1 that are still present at your facilities. 2.Fill in and sign the attached Annex no. 4 Acknowledgement of hospitals and health facilities specifying the quantity of the goods placed in quarantine, including their lot number, their code and inform your dealer and Adria Srl by sending an email to qa@adriamedical.com and export@adriamedical.com as soon as possible and in any case within 10 days of receipt of this letter. 3. Wait for information from Adria Srl for the actions regarding the concerned devices. Corrective Actions in place Adria Srl ha
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
The firm issued a field safety notice on 03/12/2019 by email. The notice explained the issue and cautioned the consignee to select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
An Urgent Product Recall letter was sent via Fed-Ex to affected customers on 12/21/2018. A second communication was sent via Fed-Ex on 01/10/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to the return any unused units that are currently in their inventory. Once returned, replacement product will be shipped at no charge. Customers were asked to complete the attached acknowledgement form. For questions contact Technical Support at 1-800-822-8837 option 1.
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may o
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
On January 28, 2019 GE healthcare notified their customers and gave the following instructions for the Centricity Universal Viewer with PACS-IW foundation 6.0.x; GTIN 00840682103800 and Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation.; Until a product modification is available to correct this issue, the following actions are recommended. 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the Universal Viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, a GE Healthcare Service representative will need to be contacted to assist with resolution of the impacted exam. Urgent cases impacted by this issue should be interpreted at the modality. 2. If DICOM storage commit is configured and in use, no commit notification is sent to the modality for images that were impacted by this issue. 3. Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue. For historical data inquiries, please contact GE service for assistance in identifying any affected images. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Due to dispenser prompting for a missed dose that had already been dispensed
On 07/02/2021, the firm initially sent out an "URGENT NOTICE" via email notifying customers of an product update correction. Customers were informed that the firm had become aware that a recent firmware update (v2.4.12) that users have experienced an error, which caused improper recording of a dispensed dose as having not been dispensed. This error may prompt a user to dispense the same dose again, and the mobile app will indicate that the previously dispensed dose has not been taken yet. Customers are instructed to: -If the pill dispenser prompts you to re-dispense a scheduled dose which has already been dispensed today, select Skip. -Use extra caution when dispensing doses prior to the scheduled firmware update and verify that the pill dispenser has a working internet connection. This will ensure that the firmware update (v2.4.14) will be automatically applied on all potentially affected online pill dispensers (at approximately 2:00 AM on July 3, 2021) to correct the issue. -To manually update firmware immediately, follow these steps: 1) Ensure the Pill Dispenser is connected to WiFi (Check for the WiFi icon on the main screen). 2) Go to the Device menu, by pressing the Center button on the main screen. 3) Scroll down and select Device Settings . 4) Scroll down and select Firmware Update. 5) Select I m Ready. The update could take several minutes. It is recommended to run the firmware update at least 30 minutes before a scheduled dose. -If the pill dispenser is not connected to WiFi, the firmware update cannot be completed. In this event, contact the Recalling Firm's Member support for assistance before continuing to use the pill dispenser to ensure the update is applied as soon as possible For question or further assistance, contact the Recalling firm at 855-855-9962 or via email at hello@herohealth.com (24/7).
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx.
Quidel issued Urgent Medical Device Correction letter on August 13, 2021. Letter states reason for recall, health risk and action to take: For samples generating a Ct value between 0 (Undetermined) and 5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the instructions above. Interpret the results according to Table 5 above. Note that if review of the original amplification curve from the neat sample is not suggestive of a positive result, processing of the diluted specimens may be deferred. If the diluted samples generate Ct values between 0 (Undetermined) and 5, please contact a Quidel Representative at (800) 874-1517 (toll-free in the U.S.) or (858) 552-1100 (outside of U.S.), Monday through Friday, between 8:00 a.m. and 5:00 p.m., Eastern for additional instructions. 1. Immediately review the revised Lyra Direct SARS-CoV-2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/138178/download 2. For clinical specimens generating Ct values <5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the Lyra Direct SARS-CoV-2 IFU. Refer to the Lyra Direct SARS-CoV-2 Assay IFU for full, detailed instructions. 3. It is recommended that any data which has been previously generated be re-evaluated and samples re-tested, as needed. 4. Complete the enclosed Filed Corrective Action Fax-Back form acknowledging receipt and understanding of the recommended actions. Return to Quidel Technical Support via fax at 858.203.9297 or via email to customernotifications@quidel.com. Representatives are available to assist you in this process and answer any questions you may have about this recall. Please contact Quidel Technical Support at technicalsupport@quidel.com or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidanc
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
On 03/28/19, Urgent Product Recall - Action Required Field Corrective Action notices were mailed FedEx Second Day to customers. The letter identified the affected product problem and actions to be taken. The firm is requesting the return of any existing inventory of these models. They are conducting an investigation of the issues. At this time, they do not have an estimated date as to when replacement product will become available. The firm urges customers to inquire as to the availability of similar products. Customers with additional questions are encouraged to call 800-424-3278 Option 1. Firm requests that customers fill out and return Customer Acknowledgement forms within 10 days of receipt of this notification.
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Cardinal Health issued a "MEDICAL DEVICE PRODUCT ADVISORY" letter and Acknowledgement Form dated 6/9/2021 via overnight mail to the direct consignees on June 09, 2021. Letters states reason for issuance, health risk associated and action to take: The caution statement on the labeling will be updated to remind the user to activate away from face and infant. The full caution statement will now state: Caution: Activate away from face and infant. If pack ruptures or contents leak, flush contact area with water. Discard pack. If redness or irritation persists, consult a physician. What actions are needed from the Customer? Please review this enhanced caution statement with your staff to ensure product activation is performed away from the face and infant. For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332. In the event you have experienced quality problems or adverse events related to the products listed above, please contact GMB-CAH-Dist-Domestic@cardinalhealth.com
October 2023
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Cardinal Health issued Urgent Medical Device Recall on 9/25/20 overnight mail. Letter states reason for recall, health risk, and action to take: 1.INSPECT your inventory for the affected product code and lot number (see Attachment A). 2. SEGREGATE and QUARANTINE all on-hand product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652- 9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by thisrecall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227; Federal Government800-444-1166 Distributor800-635-6021; All other customers888-444-54401 Cardinal intends to send a letter on 11/4/2020, to customers with an additional lot of these devices.
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
The firm, ACIST, sent an, "URGENT: MEDICAL DEVICE RECALL" letter and response form dated Jan 22, 2021 to customers on Jan. 22, 2021. The letter describe the product, problem and actions to be taken. The customers were instructed to do the following: to complete all of the steps outlined below and return the completed Recall Response Form to Stericycle by e-mail: acistmedical8961@stericycle.com or fax to 877-576-9366. 1. Check your inventory of Kodama HD-IVUS Catheter 2. Record quantities of each lot in the Response Form 3. Remove the affected lots from your inventory. 4. Use the enclosed, prepaid return label to return your affected product including a copy of the response form with the product. If you need additional labels, please contact Stericycle at 877-576-9382. If you have received any reports of illness, injury or other health consequence related to the use of product please contact Customer Support: Customer.Support@acistmedical.com Please forward this notice to those who need to be aware within your organization. If you have any further questions or concerns, please contact Stericycle at 877-576-9382.
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
On 11/23/2020, STERIS issued Urgent Device Correction notices to customers via courier service. Instructing customers to inspect and destroy any remaining affected products in their inventory. STERIS will provide replacement product at no cost to Customers who have product remaining in stock.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
On November 20, 2020, the firm sent Urgent Product Correction Notification letters to affected customers to inform them of the issue. Customers were reminded to follow product labelling regarding removing all tubes before performing maintenance or initializing the Aliquoter & Labeller Module. There should never be sample tubes present when initializing the Aliquoter & Labeller module. The firm's release of TCA Software version 4.7 is the planned mitigation for this issue. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.
On July 11, 2022, Synapse began contacting affected clinical sites where the devices were sent. An initial phone call was made to clinicians that have affected devices at their site or have patients with affected devices. A follow-up email is being sent each of the clinicians that includes a fact sheet for them about the recall, a fact sheet for patients that clinicians can forward to the patients and information about the specific EPGs that have been sent to their site. Patients are asked to register their devices at a webpage specifically developed for the purpose. Replacement devices are available from the manufacturer and arrangements are being made with clinicians and patients to have the devices programmed and delivered to patients as soon as possible. The manufacturer is asking that all devices be returned to Synapse Biomedical for disposal to ensure that no affected devices are inadvertently used at a later time.
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
On May 4, 2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice to customers via letter notifying them of calibration failures and the associated condition code for specified calibrator lots. Customers received the following instructions. " Discontinue using VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064, discard any remaining inventory and switch to an alternate lot. " Ortho will credit and/or replace all remaining inventory of VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064 as indicated on the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than MM/DD/YY, even if your facility no longer has the affected product in inventory. " Please forward this notification if the product was distributed outside of your facility.
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results should be shared with the patient s physician for interpretation and to determine when retesting and follow-up care are necessary. - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available). - Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory. On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue. Immediate Actions: - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Promptly complete and return the Customer Notification Form below t
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
Medacta issued an URGENT - Field Safety Notice to the surgeons on 10/28/2022 by email The notice provided the following information: "1. Description of advisory: The following Warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding. The updated Surgical Technique is attached to this document and can be found at: resources.medacta.com. 2. Action to take: - Transmit this communication all end-users, ensuring it is fully understood. - Verify acknowledgment through end-user signature on the attached receipt. - Return all the signed receipts to the Regulatory Department of Medacta International. 3. Contact person and return address: Stefano Baj, Regulatory Affairs Director Medacta International SA, Strada Regina, CH-6847 Castel San Pietro, Switzerland Tel: +41 (0)91 696 60 60, Fax: +41 (0)91 696 60 66"
BioGlue Surgical Adhesive, Model BG3510-5-G
Product is not approved for use in the EU and should not have been distributed in the EU.
A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45m
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.
Potential for intraoperative screw head separation at weld location.
Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form.
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices included in the packing list and instrument set are correct.
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Getinge issued an Urgent Medical Device Recall Correction letter to U.S. consignees via FedEx Priority Overnight delivery with signature proof of delivery on January 16, 2020. Letter provides identification of the issue, health risk and action to take. Customers were advised to examine your inventory immediately, complete and sign the MEDICAL DEVICE RECALL - RESPONSE FORM to acknowledge that you have received this notification, return the completed form to Getinge Disinfection AB by e-mailing a scanned copy to swic46-series.us@getinge.com or by faxing the form to 1-800-574-5051. Should you have one or more Getinge 46-Series Washer Disinfectors (models 46-4-502 and 46-4-503) you will be contacted by a Getinge Service Representative to schedule on-site service of your device, free of charge, by a Getinge Service Representative. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Beginning the week of November 7, 2017, all affected US customers will be sent a field correction notification letter along with a Technical Service Bulletin (TSB) to explain how to assure the misconfiguration does not affect their system performance. For Distribution outside the US, the same letter and TSB will be sent to the initial consignee and they will execute the delivery of the Field Correction Notice and will inform the Recalling firm of the responses.
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
On 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: jhanka@helena.com
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient
Intersurgical Inc. issued Urgent Medical Device Recall Letter via email on 08/29/2022 and via certified first-class mail to Distributors. Letter states reason for recall, health risk and action to take: The recall extended to the user level. Recall Instructions: i. Immediately discontinue use and quarantined any stock with the product/lot number described above in this recall notification. ii. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. iii. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. i. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: ii. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. iii. The subject line should contain your Company name and RGA number. 1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. iv. Intersurgical will credit your account when the product is received. v. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. vi. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. vii. The subject line should contain your Company name and Intersurgical Recall. Contact :315-451-2900 ext. 500 or email: kcambpell@intersurgicalinc.com.
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
On May 2021, ViewRay issued an "Urgent Medical Device Correction" notification to all affected consignees via E-Mail. All affected consignees were outside of the US. In addition to informing consignees about the recall, ViewRay asked customers to take the following actions: 1. We will provide an update to customers when new information is available. Until that time: 2. Customers should be aware of these software anomalies and the behavior of the system described in this letter. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification. 4. Any device-related incidents should be reported to ViewRay, ViewRays distributor or local representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the Competent Authority if appropriate or to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 5. If you have any questions related to this letter, please contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875 toll free 24 hours a day, 7 days a week.
VITROS 250 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
On December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers.
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
Urgent Medical Device Recall Notification letters dated 6/25/21 were sent to customers. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Determine your current inventory of the affected lot within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Removal Acknowledgement," form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Removal Acknowledgement" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to ( 610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of this affected product as identified in the "Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMl Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Medical Affairs Department at 1-800-854-6851.
Kit: Central Line Dres Change 20/Cs
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.
Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Instructions to Consignees 1. Locate and quarantine affected product in your possession. 2. Determine the number of affected devices in your possession and complete the Response Form 3. All affected product must be returned to Sedgwick for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. Instructions to Distributors DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
On 10/20/2020, the firm, ViewRay, Inc, emailed an "Urgent Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm asked consignees to take the following actions.: 1. For Customer using TPDS software ver. 5.2.5 or earlier with optional 3 Plane imaging: - Do: Maintain a distance of at least 5 cm (~2) between the receive coil and the inner surface of the bore wall when using 3 Plane cin treatment imaging (Figure 3 & 4). - Do Not: Select 3 Plane cin treatment imaging if a distance of at least 5 cm (~2) cannot be maintained between the receive coil and the inner surface of the bore wall during treatment. 2. For Customer Using TPDS software ver. 5.3 or later with optional 8 fps enabled: - Do Not: Use 8 fps cin treatment imaging until further guidance is provided by ViewRay. - Do: Use 4 fps cin treatment imaging when treating a patient. 3. If you have any questions related to this letter, please contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875.
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
The firm initiated their recall by visit on 04/07/2021. VERO Clinical Educators are going (or have gone) onsite to the hospitals to physically upgrade the software to v2.2.4. The correction of upgrading the software from v2.2.3 to v2.2.4 began on Wednesday April 7, 2021. The software upgrade is expected to be completed by Friday April 23, 2021. For questions contact VERO Biotech at 1-877-337-4118 or visit the VERO Biotech website at https://www.vero-biotech.com/.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Between 10/14/2016 to 10/21/2016 a notification was emailed to the affected users informing them that Assay protocol had changed due to a Marketing decision to delete use of EDC, since it was a discontinued device (for over 10 years), creating a tighter assay range, but met QC specification. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range, Technical Services began an MRA investigation. Investigation verified user complaint, and Lot was quarantined, and Rework action plans using EDC also were initiated for the device. This issue was found at a Users site, via use as system Quality Control material. The investigation focused on potential effects/risks, and cause. This issue was found at a Users site, via use as system Quality Control material. Customers reported a narrow assay range when compared to prior lots forcing some users out of the provided assay range. PUBLIC CONTACT: Title: Technical Services Manager Address: 1530 Lindbergh Drive, Beaumont, TX 77707 Telephone #: (409) 842-3714 x1177 Email: jhanka@helena.com
ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
On 02/25/2021, Depuy Synthes issued an Urgent Medical Device Recall notices to customers via email. DePuy (Ireland) UC is initiating a voluntary removal for the 12 lots for ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: smithsmedical-Jelco2021@novasyte.com The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.
XARIO 100 TUS-X100 diagnostic ultrasound system
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed to call 800-521-1968.
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
The recalling firm initiated issuance of recall letters dated 12/9/2021 on the same date via email, phone, USPS, or UPS to their end-user customers. The letter explains the issue, the potential health hazard, and the necessary actions to be taken. The actions included to discontinue use of the affected product and isolate the products in their facility; assess risks and consequences for the use of the defective product in accordance with the consignee's procedures and take the appropriate action; and complete the attached Product Disposition Site Confirmation form and FAX it to the recalling firm. The form is a confirmation that the affected product has been discarded/destroyed. The product will be replaced by the recalling firm. The Customer Disposition form says if they have further distributed the product, they should provide the customer contact information to the recalling firm so that further follow-up can be made. For distributors. the letters were issued on 12/10/2021 via email. The email requests the distributor to provide a list of their customers to the recalling firm for further follow-up or to perform a subrecall themselves to the end-user customers. The distributor recall letter describes the problem and instructs the distributor to stop distributing the product and isolate it. A Product Disposition form was enclosed for completion to be returned via FAX or email. The recalling firm would then contact the distributor as to return or destruction for the product. The letter also informs the distributor it is a legal obligation to notify customers, therefore, they are requested to provide a list of their customers who have received the affected product, even though the cover email gives them the option of contacting the customers themselves.
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.
A Recall notification letter titled, "Urgent Product Recall" was sent to distributors on 03/29/2021 via email and to 19 end users via email on 04/01/2021. First notification mailing to all other end-users will be via UPS. First notification mailing to all other end-users will be via UPS. Assembling the mailing is in-process and the firm will notify FDA on the mailing dates and responses in their next report. Consignees were also notified by phone. The letter instructs the direct consignee to stop using the above-mentioned product (concerned item/lot) immediately and isolate defective products in the consignee facility; assess risks and consequences for the use of this defective product in accordance with the consignee's procedures and take appropriate action; complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 800.726.0052 or email to patech@gbo.com. This form is to confirm that the consignees have discarded/destroyed all products from these items/lots. The firm will replace the product after the completed form is sent to Greiner. The notice sent to the distributors instructs them to stop distributing the above-mentioned product (concerned items/lots) immediately and isolate defective products in their facility. Complete the attached Product Disposition form and fax it to Greiner at 800.726.0052 or email to patech@gbo.com. The firm will contact the distributor for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. The firm will use this information to send you replacement stock or issue a credit. The firm informs the distributor that it is a legal obligation to notify customers. Therefore, the firm is requesting that the distributor please provide them with a list of their customers that have received the item with this specific lot number. Include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. Please provide this as
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Canon sent an Urgent - Medical Device Correction letter dated January 4, 2018. Customers were notified of the issue and informed that a modified firmware will be installed to correct the issue. When that modified firmware becomes available, the Toshiba service representative will contact customers to schedule an appointment to install the firmware. Until the modified firmware is installed, instructions were provided to confirm that the main power switch is sent to OFF, insert the power plug into the power outlet, and to set the main power switch to ON. The system should be operated according to the procedure described in section 9.1, Connection the Power Cable and Protective Grounding, in the operation manual. Additionally, customers were asked to complete and return the attached Customer Reply Form. For further questions, please call (714) 730-5000.
STOCKERT Heater-Cooler System 3T, 230 V
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
"Consignees were sent a recall notification, dated 06/30/2017, via mail. Instructions included a recommendation from LivaNova to use its oxygenators, or other oxygenators that are equipped with compatible heat exchangers, to ensure that the permeability rate is within the prescribed allowable limits (ALs). Depending on whether or not the oxygenator was from LivaNova, there were specific instructions to follow for each type and source. Consignees were also instructed to complete and return the Confirmation Form. If product was further distributed, the firm asks that further customers be notified of the recall and that customers contact the LivaNova Quality Assurance Team at usfsn@livanova.com. Questions regarding the recall can be directed to 800-986-4702 or 3T.US@livanova.com. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program."
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Engraving on implants may not match what is listed on the pouch labels.
A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to rs.sdmriskmgt@medtronic.com. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Arrow International, a subsidiary of Teleflex issued an "URGENT - FIELD SAFETY NOTICE" consignee notification letter on 20th Sept 2021 via FedEx 2-day mail to medical facilities and distributors. Letter states reason for recall, health risk and action to take: We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. Should you require any further information or support concerning this issue, please contact: Customer Service Telephone: 1-866-396-2111; FAX: 1-855-419-8507 or E-mail: Recalls@teleflex.com.
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
The device was not cleared for U.S. distribution.
The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory
Imactis notified users by visit on 2/11/221 and issued Urgent Medical Device Recall on 2/25/21 via email to consignees. Letter states reason for recall, health risk and action to take: Customers are requested to quarantine any product from the affected NaviKit" lot numbers and return them to Imactis Affected NaviKit lot numbers will be quarantined and removed from the market. New compliant product will be sent to customers to replace the removed lot numbers. As the defect is visually detectable, product will be inspected internally according to an approved procedure and any defective needle holders will be sorted and replaced with compliant ones. Refurbished NaviKit" product will not be sold to customers. Your IMACTIS representative for questions: Robert Hornak (VP Sales, North America) - 205-542-1486 (Cell) - 205-542-1486 (cell) Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional
Oakworks issued Urgent Medical Device Recall letter dated 6/29/21. Letter states reason for recall , health risk and action to take: Actions to be taken are to immediately examine your inventory of OAKWORKS Inc., Ultrasound Vascular Table without Fowler (V1) and Ultrasound Vascular Table with Fowler (V2) to identify and locate all affected product(s). Do not distribute these affected product(s). Please quarantine the table(s). For tables that have been in use, they remain fully functional. Implement the field action as described below for the product listed in the Product and Distribution Information. Enclosed is a Medical Device Advisory Notice Response Form for each product we believe you have. Please complete this form in its entirety and return to OAKWORKS Inc., within 48 hours of receipt of this advisory notice via any of the options listed below. If you have further distributed this product, immediately contact your customer(s) with a copy of this letter and all applicable response forms. Then, provide OAKWORKS Inc. with the contact information for your customer(s) to whom this product(s) has been distributed by using the Medical Device Advisory Notice Response Form within 48 hours. Please note that you are required by the United States Food and Drug Administration to contact your customer(s) who are currently in possession of the product and inform them of this Medical Device Advisory Notice. MAIL: Oakworks Inc. EMAIL: qualitycare@oakworks.com Attn: Quality Care MDAN Response FAX: (717) 235-6798 923 East Wellspring Rd. New Freedom, PA 17349 What OAKWORKS Inc. will do next: Upon receipt of the Medical Device Advisory Notice Response Form(s), and to minimize the downtime of your OAKWORKS Ultrasound Vascular Table (V1) or (V2), we will setup a service visit to replace the Tilt Actuator Bracket on the table(s). The correction installation takes approximately 30 minutes. The replaced bracket will be disposed of by the service provider. If you have any quest