FDA Device Recalls in 2014
1,151 recalls found
December 2014
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical
Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.
Focus Diagnostics sent an Urgent Safety Notice Correction letter dated May 15, 2014, to all affected customers. The notification, informed customers of the product, the problem, and the action to be taken by the customer. To decrease the likelihood of obtaining any false results caused by either manually entering a spectral matrix or storing the DAD improperly after each use, please follow the recommended warnings and precautions provided in the revised and attached Simplexa Flu A/B & RSV Direct (PI.MOL2650 Rev. D) package insert. 1. The spectral matrix must be installed in each 3M Integrated Cycler and should not be changed unless an updated QR code for the instrument is provided by Focus Diagnostics. The spectral matrix is unique to each 3M Integrated Cycler. The spectral matrix was provided with the 3M Integrated Cycler instrument on the cover of the 3M Integrated Cycler Hardware Manual. If the matrix label will not scan or cannot be found, contact Focus Diagnostics. The contact information is on the last page of this document. 2. Not installing or changing the spectral matrix can result in false results. 3. After each use store DAD discs flat with the numbered foil side up. Customers were instructed to acknowledge that they have received this notification by signing the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at 562-240-6526 within 10 business days. The Notice of Correction and Acknowledgement Form was sent to customers on 05/15/2014 via email and USPS mail. Additional customers were notified on 05/29/2014 via email and USPS mail. For questions regarding this recall call 714-220-1900.
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well. Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.
PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 130.
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.
BAG 9732315 MOUSE STERILE 15 PK
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative. Beckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.
Beckman Coulter sent an customer notification letter dated 11/8/13 to all customers who purchased the LH 750 and LH 780 Hematology Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com/customer/support or call (800) 526-7694 in the US and Canada. Outside the US and Canada, customers are instructed to contact Beckman Coulter Representative. On 2/17/14, Beckman Coulter expanded the recall to inform Coulter LH 750 and Coulter LH 780 Hematology Analyzer customers of the issue related to LH Cleaner and Coulter Clenz.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 8, 2014 via first class mail. The letter identified the reason for recall, product information, issue, impact, action, resolution, contact information, and customer response form. Customers are advised to review historical quality control (QC) data and System Check results, and determine whether a review of patient test results is warranted. For questions regarding this letter, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com/customersupport/support, By phone: call 1-800-854-3633 in the United States and Canada, and Outside the United States and Canada, contact your local Beckman Coulter representative
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Toshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information.
PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.
Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visuali
LED battery chargers may prematurely fail and will not charge the LED battery as intended
Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
Notes associated with prescription are not printed to the prescription or to the patient chart.
Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.
SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.
Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.
The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Consultant.
Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.
Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.
Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back p
LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All
SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover. To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods: Mail provided postage paid envelope Fax 610-251-9005 Scan/e-mail to FieldAction@synthes.com For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.
SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladde
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Convatec sent Urgent: Voluntary Medical Device Recall letters dated 2/7/2014 via UPS and email. Foreign customers were provided the notice via DHL. The letter identified the affected product, problem and actions to be taken. Customers are asked to perform a count of recalled product in inventory. All consignees should be contacted and be instructed to return product based on their procedures. Customers were instructed to complete and return the enclosed respoonse form.
Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
In 2010, Zimmer initiated a recall of the Bigliani/Flatow Fukuda Retractors due to fractures occurring at the grooves around the perimeter of the blades. Zimmer is expanding this recall to include seven lots that were not previously included. On 5/23/13, an Urgent Medical Device Recall notification letter went to all consignees explaining the recall expansion and risk associated with the recall. All consignees are to locate and quarantine the device immediately. Please return the product along with the completed inventory certification form to Zimmer. If you have any questions regarding this recall, call Zimmer at 877-946-2761.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod con
Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.
Integra LifeSciences initiated this recall by sending recall notification letter to US consignees, delivered by traceable courier service. Non US consignees notified of the recall by either traceable e-mail or facsimile. The letter dated, January 23, 2014, titled "URGENT: VOLUNTARY MEDICAL DEVICE RECALL Integra Malibu Polyaxial Drivers Catalogue Numbers: 91-2109 & 91- 2110", informed customers of the recall and provided product description with codes, picture of the product, advised customers to: Inspect their inventory of Malibu Polyaxial Drivers. - If you have product(s) with a lot number listed on the following page, STOP USING THEM IMMEDIATLY. - If you do not have Drivers with a lot number listed on the following page, you can continue to use them. Customers were also instructed that regardless if they have Drivers with the affected lots, to complete the attached form and return it to Integra as indicated. Customers were instructed to keep a copy of the form for their records., and contact information. Customers with questions were instructed to contact Customers Service at 1-866-942-8698. For questions regarding this recall call 609-275-0500.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
An Important Product Removal Notification dated September 20, 2013 was sent to customers.
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of sp
Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.
Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them. 2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can continue to use it. The event has been isolated to this single lot. 3. We also request that regardless if you have a UCR Driver with the affected lot, you complete the attached form and return it to us as soon as possible as indicated. We recommend you keep a copy of the form for your records. 4. When your form is received, Customer Service will contact you and provide an RMA number, directions to return the product, and input an order to replace the quantity you indicate on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-866- 942-8698. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort. : .
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain.
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
In June, 2014, an urgent medical device correction field safety notice of improvement was sent to end users informing them of the product, problem, and action to be taken to avoid the potential safety issue.
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)
The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated October 23, 2013 to its customers. The firm also sent a follow-up letter dated October 30, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed Until a service visit is scheduled, do the following: Instruct the laboratory staff to recognize this sequence of events and Ensure that whenever the operator disables a method on an Aptio system or a CentraLinksystem and replenishes reagent for that method, the operator then confirms that the method remains disabled in the CentraLink system or disables it again. The operator must allow up to five minutes to verify that the test remains disabled. In addition, the customers were instructed tocomplete and return the FIELD CORRECTION EFFECTIVENESS CHECK response form via fax to Siemens Healthcare Diagnostics Customer Care Center at 800-441-9250, and to retain this letter with your laboratory records, and forward this letter to those who may have received this product. After a service visit is performed and an interim solution is implemented, the laboratory staff will be trained on this update to understand the minor but necessary changes in the workflow. If you have any questions, please contact your Siemens Customer Care Center at 800-441-9250 or your local Siemens representative.
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.
Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link. Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300. .
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immun
A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
Siemens sent an Urgent Medical Device Correction letter dated April 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be Taken by the Customer 1. If an Air Compressor has already been delivered to your laboratory, or is delivered in the future for installation by your Siemens Healthcare Customer Service Engineer, please do not make any attempt to install the Air Compressor by yourself. 2. Please notify your local Siemens Healthcare Diagnostics Customer Care Center when an Air Compressor is at your site so arrangements may be made for installation by a Siemens Healthcare Diagnostics Customer Service Engineer. Please discuss the content of this letter with your Medical Director. Please complete and return the Field Correction Effectiveness Check Form attached to this letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.
Siemens sent an Urgent Medical Device Correction Field Safety Notice dated was sent to end users on/about May 6, 2014, to notify them of the safety issue and provide instructions to avoid potential risks. Customers were instructed to make sure all computers with the LANTIS client software installed are running on an operating system that was validated by Siemens for opration with LANTIS, e.g. Microsoft Windows XP Service Pack 3 (SP3). Customers were asked to include the Field Safety Notice in their System Owner Manual chapter "Safety Advisory Letters" where it should remain and that all affected personnel affected be informed. For questions regarding this recall call 1-610-219-6300.
Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtro
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to dover.repairs@zimmer.com . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to CorporateQualitv.PostMarket@zimmer.com. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. PostMarket@zimmer.com or call 1-330-364-0989.
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
Siemens sent an Safety Advisory Notice dated April 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. What steps can the user take to avoid the potential risk of this issue? Press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. How will the issue finally be resolved? Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available by end of May 2014. We appreciate your understanding and cooperation with this safety advisory notice and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory notice is placed in the system's instructions for use until the update has been installed. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. For further questions please call (610) 219-6300.
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product.
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: Techsupport@itcmed.com Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
A reagent contained within the product may return false negative results.
The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
On March 26, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL NOTIFICATION to their consignees via mail and email. Notification included product description, reason for recall, risk to health, and actions to be taken by the Customer/User. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Angela Ragainis/Kelly Jo Whipple 269-389-4354 / 269-389-2921 angela.ragainis@stryker.com / kellyjo.whipple@stryker.com Customers will be asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers will return affected product to Stericycle for destruction using a return label provided by Stryker or Stericycle. Upon receipt of affected product a credit will be issued to customer account. In addition, facilities are being asked to research their records for patient issues that may have been associated with the use of a recalled device, such as infection and/or inflammation.
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
ELITech sent an Urgent Product Recall Notice letter dated August 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To All Users, ***Effective immediately, please discontinue using this product.*** Actions to be taken: "Laboratories must not use this product and must destroy all remaining inventory of the product. "If you have transferred any of this product to another location, please forward a copy of this bulletin to that location. "All users receive ENVOY 500 AST REAGENT KIT, reference 55255, from distributors. To be certain everyone who is possibly affected by this is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. On August 20, 2014:, customers were contacted with an interim solution. On September 3, 2014, the firm sent Technical Bulletin 5056 and Distributor Notice D057/Customer Notice C061 to all Envoy users notifying that the recalled Envoy AST Reagent (ref 55255) was being discontinued; the old Envoy AST Reagent (ref. 55250) was being reinstated. On September 23, 2014, the firm sent the URGENT: PRODUCT RECALL NOTICE "UPDATE", dated 19 September 2014, to all Envoy users stating that old (original) Envoy 500 AST Reagent Kit (ref 55250) will replace the recalled Envoy 500 AST Reagent Kit (ref 55255). As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. Customers with questions about this recall, please call the Technical Support at 1-855-354-8324 (1-855-ELITECH).
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Biomet 3i sent a Medical Advisory Notice dated October 3, 2013 via mail, facsimile or telephone to all affected customers. The notice identified the product, the problem, and the action to be taken by the customers. The customers were instructed to do the following: 1) Review their inventor for any incorrectly labeled products and return them to their local Biomet distributor. 2) Provide this information to persons in their organization that uses or order these products. 3) Ensure that a copy of this letter is provided to any other organization to which the products maybe have been transferred. Customer were also instructed to respond to the attached Response Form via fax at 561-514-6316 or email to: domesticcomplaints@biomet.com. For any questions or concerns, call Biomet 3i Customer Service at 1-800-342-5454. For questions regarding this recall call 561-776-6706.
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority has been informed of this update. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. Further questions please call (610) 219-6300.