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Displaying 1 - 15 of 240 items.

Health alert or recall NCB Screw 5.0 L=38
Zimmer GmbH is conducting a medical device field safety corrective action (removal) for one lot of the NCB femoral screws. The product in scope is part of a mix-up with a NCB humeral screw that differs in dimensions and therefore it has been decided to…
RecallHealth product recall | 2022-06-27
Health alert or recall Aquac Uno H Reverse Osmosis System - Main Unit
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been…
RecallHealth product recall | 2022-06-27
Health alert or recall Merlin Patient Care System - Programmer Software
Abbott is notifying customers of the potential for programmer software (Merlin pcs) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality,…
RecallHealth product recall | 2022-06-27
Health alert or recall Intraosseous Powered Drive and Needle Kits
1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2.…
RecallHealth product recall | 2022-06-27
Health alert or recall Fingertip Pulse Oximeter
Voluntary recall-interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Infrared Thermometer
Voluntary recall-interim order authorization not approved.  Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Digital Thermometer
Voluntary recall- interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Tps System - Elite Burs
During internal product/process review (April 2022), it was discovered that there is a potential for the core diameter to be undersized, which may lead to the router breaking. To date, Stryker has not been made aware of any adverse events related to this…
RecallHealth product recall | 2022-06-27
Health alert or recall Defigard Touch7
In rare cases, when the device is switched on directly in defibrillator mode, cancellations of heart rhythm analysis after 30 seconds have been reported. Recall start date: June 17, 2022
RecallHealth product recall | 2022-06-27
Health alert or recall CT Scan and High Capacity Table
During a specific servicing activity, if the wrong screws are removed by the service personnel without the appropriate table supports in place, there is the potential for the table to drop. Recall start date: June 6, 2022…
RecallHealth product recall | 2022-06-20
Health alert or recall Modular Cathcart Fracture Head
During an internal review, it was determined that the Cathcart head includes a +5mm offset, which was not specified in previous versions of the self-centering bipolar and Modular Cathcart unipolar endo heads surgical technique…
RecallHealth product recall | 2022-06-20
Health alert or recall F/O Laryngoscope
Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n…
RecallHealth product recall | 2022-06-20
Health alert or recall Ambu Vivasight 2 Dlt Kit
Ambu has received complaints on Vivasight 2 Dlt concerning leak/rupture of either the bronchial or tracheal cuff. Leakage occurred during procedure could potentially lead to loss of secure airway and will require re-intubation…
RecallHealth product recall | 2022-06-20
Health alert or recall Zero Footprint Client
GE Healthcare has become aware of two issues related to a potential to display inaccurate measurements on images in centricity universal view Zero Footprint Client (zfp). Recall start date: June 9, 2022…
RecallHealth product recall | 2022-06-20
Health alert or recall Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/…
RecallHealth product recall | 2022-06-20
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