FDA Device Recalls in 2024
527 recalls found
January 2024
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
GM Helix Acqua Implant 3.5x10, Article No. 140.944
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.
SOMATOM Force with software syngo.CT VB20 Model #10742326
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If you have any questions, please contact our service organization at at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Distributed product did not undergo proper release testing.
All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to recall@microbiologics.com.
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to recall@microbiologics.com, and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or recall@microbiologics.com.
KWIK-STIK" plus: Clostridium perfringens
Labeling error.
The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.
Centricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
ICU Medical notified customers, via Stericycle, Inc., on about 07/29/2019 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Customers were instructed to check inventory and quarantine any sets that are affected by the recall, return them to ICU Medical, inform potential users within your organization of the recall, and complete and return the provided response form. Please notify customers if affected product was further distributed and request that they contact Stericycle at 1-855-311-5437 (M-F, 8am-5pm ET) to receive a reply form. Customers were also requested to consider the following situations: 1. In applications where the use of a filter is not deemed necessary, consider utilizing an administration set without a filter. 2. In applications where filter use is desired and microbore tubing is not required, consider using filtered macrobore sets in place of microbore sets. 3. In cases where a filtered macrobore set is desired but no alternative macrobore set is available contact ICU Medical because a non-filtered set along with an add on filter or filtered extension set could be considered. 4. In instances where the benefits of a filtered microbore infusion set are greater than the potential risks of a filter leak, the product affected by the recall may be utilized out of medical necessity. In these cases, an individualized assessment of benefits and risks should be undertaken with consideration of the unique characteristics of the patient and the infusion itself. When the benefits exceed the risks and the set is deemed medically necessary, users should periodically monitor the vented filter area for leakage. If leaking is observed, consider changing to a new infusion set as soon as clinically appropriate. Report this event to ICU Medical.
Unity Total Knee System. Used for knee prosthesis in total knee replacement
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to vigilance@coringroup.com. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to vigilance@coringroup.com.
Synaptive Trackable Suction Set Standard and Malleable
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
On April 23, 2021 the firm sent a letter to its consignees with the following instructions: 1. Quarantine and discontinue use of all Synaptive Trackable Suction devices. 2. Contact Synaptive Recall Support at 1.866.853.8001 or by email at RecallSupport@synaptivemedical.com. Customer service will schedule an on-site inspection of each device. If this is not possible, arrangements will be made to have all impacted units returned to Synaptive. 3. Once on-site inspection or return of your stock has been arranged, please complete and return the attached Acknowledgement and Receipt Form. All forms should be submitted by email to RecallSupport@synaptivemedical.com. Note: If you are in North America and your account is supported by a Synaptive Clinical Applications Specialist (CAS), then a company representative may have already visited your site and conducted the necessary inspections. If so, we kindly ask that you still complete the Acknowledgement and Receipt Form for our records. 4. Upon inspection, all units will be graded as pass or fail. Units that pass meet normal specifications and are safe for continued use. These devices will be returned and released back into circulation. Failing (i.e. defective) units will be removed immediately and replaced by Synaptive at no cost.
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
The spreader bar can disconnect from the scale bottom attachment.
Customers identified as owners of the affected scales will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice. Affected customers need to ensure that all caregivers and users of the affected devices are made aware of the Field Safety Notice. There will be two options for customers: - Contact Arjo to order parts and instruction required to proceed with the disconnection of the affected scale by on-site biomed personnel to continue to use the ceiling lift safely, or - Contact Arjo to ask to an Arjo service technician to visit a customer facility to perform the scale disconnection to continue to use the ceiling lift safely. The Field Safety Notice will be accompanied by Customer Response Form. Following its return to the local Arjo office and the availability of the permanent solution, a customer will be contacted to complete the action.
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact laura.storms@olympus.com for additional information.
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.
The firm notified the major distributor who received this product on or about 06/14/2018 via a letter entitled "URGENT: Voluntary Medical Device Recall for Clarity 10SG Urinalysis Reagent Strips". The distributor letter stated effective immediately, the purpose of this letter is to advise that Clarity Diagnostics LLC is voluntarily recalling Clarity 10SG Strips Lot# URS7100027EX, Exp:11/2019 , URS7100140EX, Exp:11/2019 and URS8010016EX, Exp: 03/2020. The affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers which is why the recall is being performed. The letter also stated to ensure that communication is relayed to Clarity Diagnostics customers. Once the three lots have been secured, Clarity Diagnostics will follow up with the distributor regarding the disposal of the product. Clarity Diagnostics provided a telephone number for any customer concerns. Clarity Diagnostics has taken appropriate steps to assure that this problem will not reoccur in the future. Clarity Diagnostics also provided a letter to the distributor on or about 06/22/2018 entitled "URGENT PRODUCT RECALL". This letter was provided for distributor to notify its customers. This letter provided notification of a product recall regarding specific lots of Clarity Diagnostics - 10SG Urinalysis Reagent Strips. This notice has been issued because the affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers. Affected product first shipped April 5, 2018. Questions can be directed to the Clarity Diagnostics individual handing the recall---Ashish Parikh at Clarity Diagnostics (877) 722-6339.
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Due to product label/labeling being altered from it's approved state.
On 11/11/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" notification letter to customers informing them they discovered that the labeling sent to customers were not the approved version of the product labeling. The labeling was missing the following items; warnings, cautions, precautions, anticipated adverse events, indication for use, contraindications, software overview and software description. The incorrect labeling could result in the following risks/hazards/harms: - A lack of understanding of the Indications for Use of this software. - Use of the software by someone who is not a dental professional and does not have a thorough understanding of the dentistry and orthodontic principles, clinical applications, and risks. - The improper use of poor-quality dental scans as an input for treatment planning. - The lack of knowledge of the tools available for use during collision detection. - The sale of this product to someone other than a dental professional. - The user not knowing that they needed the necessary product training to use the software. - A lack of understand that a failure to observe all warnings and precautions may result in complications. - A lack of knowledge of theoretical adverse events that could result during sequential aligner treatment, after using this software. - A lack of knowledge regarding the technical description of the product. - A lack of knowledge regarding the technical requirements of the system. - Poor fit, possibly resulting in: ++ Poor fit ++ Infection ++ TMD ++ Crown Removal - Inappropriate tooth movements, including: ++ Nerve Damage ++ Pulpal Degradation ++ Gingival Recession ++ Root Resorption ++ Tooth Extrusion ++ Tooth Loss ++ Unintended tooth movement Customer are informed to: 1) Read the document (MKT-LB-005) that is included with the the customer notification. The document includes all information missing from the label sent with the delivery of the product. 2) Send a read receipt associated with the ema
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency.
On 02/01/2021, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Notification Letter to inform customers that the Recalling Firm has identified that there is a software anomaly in the Analyzer Software subcomponent called Suhaili Service (version 2.0.3 and earlier) that is affecting the Analyzer. Suhaili Service controls raw data processing based on assay configuration data from Sample Prep software. Processed results are sent to Sample Prep software for patient result reporting. This anomaly, as a result of this interface, has a potential risk of reporting wrong patient results for Vitamin D. Customers are informed, As an immediate correction the following instructions must be followed with Cascadion SM Clinical Analyzer Software versions 2.0.2 and earlier until the installation of the new software version 2.1. 1. Please distribute this information immediately to any staff that may be impacted by this issue. 2. Please change the Quick Connect Cartridge Cs on the instrument to new ones. 3. After the cartridge change, if a sample is reported to have concentration of total 25-hydroxy Vitamin D below assay measuring range, follow these instructions to prevent the error from being reported: a. Repeat the sample analysis with a Cascadion SM Clinical Analyzer b. In case the repeated result is below assay measuring range, the sample should be rerun on another assay and platform. 4. Retain a copy of this letter for your laboratory records. 5. As appropriate, contact your Medical Professional for evaluation of further action. 6. Please, fill out the MEDICAL DEVICE RECALL- Response Form and return it within 5 days of the date of this letter to your manufacturer as instructed in the form and as listed: Email: vigilance.clinical.fi@thermofisher.com The actions to be taken by the Recalling Firm: 1. The Recalling Firm has informed the appropriate Regulatory Agencies. 2. When, available, the final corrective action will be to update Clinical Analyzer software v2.1
In-View Clear Leggings Sterile
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
A Recall notification letter titled, "URGENT MEDICAL DEVICE RECALL" was sent to consignees on 02/25/2021 via FedEx priority overnight. The consignee is requested to follow the following instructions: 1. CHECK all storage and usage locations to confirm whether they have any units of the affected product codes and lot numbers listed in Attachment 1. 2. SEGREGATE and QUARANTINE all impacted on-hand product. 3) 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 they have quarantined. They are requested to please respond regardless of whether or not they have affected product. 4. NOTIFY any customers to whom they may have distributed, or forwarded product affected by this recall. The consignee's notification to their 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. 6. CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it.
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
On April 29, 2019, consignees were notified by letter via Federal Express and/or federal mail. The Field Safety Alert informed customers that the priming volume values printed on the MAHURKAR and Argyle acute catheters and Instructions for Use are higher than the volumes required to fill each lumen. The firm will update the IFU for the affected products to provide clarity on the printed priming volumes. In the meantime, the firm recommends the use of a non-heparinized lock solution, such as 4% sodium citrate or 1000 U/mL heparin to mitigate potential risk associated with unintended administration of additional concentrated heparin. The firm asks that customers complete and return the acknowledgement form accompanying the notification even if they do not have affected inventory. If you have experienced quality problems or adverse events, you may contact the firm at quality.assurance@covidien.com.
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
On 12/17/2021, the firm notified affected customers via email using a letter titled, "URGENT MEDICAL DEVICE CORRECTION FA-CP-MUN-2021-001." The letter indicated the following actions to be taken by the customer: Using the attached Customer Response Form (Attachment 1), please respond by email to LivaNova.FSCA@livanova.com to confirm the receipt of this letter and that you have read and understood its content. No further action is requested. A LivaNova authorized technician will contact you to schedule an appointment and correct the devices with the missing ferrite ring. Any affected device currently in use may continue to be used without limitation. For questions regarding this Medical Device Correction, please contact a LivaNova sales rep or send an e-mail LivaNova Quality Assurance Team at LivaNova.FSCA@livanova.com. Please, complete this response form and return it via e-mail to LivaNova.FSCA@livanova.com no later than December 31st, 2021.
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units.
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
Konica Minolta issued Urgent: Medical Device Recall lmagePilot Versions 1.92 and 1.93 Letter to Dealers on 12/8/21 and Customers on 12/15/21 via Fed'X. Letter states reason for recall, health risk and action to take: To ensure the correct sampling pitch is obtained from the AeroDR or Momentum panel, please refer to the enclosed "lmagePilot & AeroDR Start-up Sequence and Notice before Shutting Down lmagePilot." Konica Minolta has issued a countermeasure to minimize the risk of a potential incident. This corrective action can only be carried out on site by a Konica Minolta trained representative. Konica Minolta Healthcare or Business Partner will contact each site to schedule a visit. A Konica Minolta Representative will be contacting you within 30 days to schedule a visit. The dispatched representative will perform a check and repair process and alert the customer if any repair was needed to any of the images on the lmagePilot server. If image repair is needed, we recommend the images that were previously sent to PACS, NAS or burned to media be exported again. Questions contact your Konica Minolta representative or the Konica Minolta 24-hour Technical Support Department at 1-800-945-0456.
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Product labeled as Cutting Electrode may contain BIVAP electrode.
The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device.
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
On 01/21/2021, CooperSurgical issued Urgent Medical Device Recall notices to customers via certified mail. On 9/08/2021, CooperSurgical expanded the recall adding an additional lot and notified customers via courier service. Customers were advised to: - Discontinue use of and isolate all products subject to the recall. - Complete the Acknowledgement and Receipt Form, and return via email to recall@coopersurgical.com or fax to 203-601-9870. - Once the Acknowledgement Form is received, Cooper Surgical will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same Form to indicate that and return it to CooperSurgical. Customers with questions, please call 203-601-5200 ext. 3300.
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Philips issued customer notification on 08/19/2019 and delivering on 08/23/2019 via priority mail. Letter states reason for recall, health risk and action to take: Customers with affected cables installed need not take any immediate action. The cables subject to this recall do not affect the normal operation of MX4O System with Smart Hopping Infrastructure. Philips Healthcare will contact you to schedule a service team to replace affected cables. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.
SICAT IMPLANT V2.0
A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.
On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.