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Displaying 1 - 15 of 424 items.
Zimmer Biomet Canada is initiating a lot specific recall for the Zimmer dermatome blades (00-8800-000-10) in Canada. There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The issue would…
RecallHealth product recall | 2023-09-21
In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the armed state). However, there were reported events where…
RecallHealth product recall | 2023-09-20
GE Healthcare has become aware of an issue where images from two different patients may be contained in a single study when stored in Centricity Enterprise Archive (EA) and/or Enterprise Archive (EA). This issue could contribute to an adverse patient…
RecallHealth product recall | 2023-09-19
It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures.
Recall start date…
RecallHealth product recall | 2023-09-18
There was a gas filter used in a fluid bearing line of the custom tubing pack. All computed tomography perfusion (CTPs) that were manufactured before the introduction of the new filter type and have not yet expired are affected. Preventive measure: a new…
RecallHealth product recall | 2023-09-15
Abott is informing customers of a rare potential for a bluetooth circuit component issue on subset of Neturino Implantable Cardioverter Defrbrillators (ICDs) and Cardiac Resynchronization Therapy Defribrilators (CRT-Ds) manufactured prior to April 2022.…
RecallHealth product recall | 2023-09-15
Reports of system error during preoperative calibration self-tests of the Hugo robotic arm cart assembly. After recalibration attempt, the robotic arm cart assembly will be prevented from entering teleoperation even if the calibration is successful. This…
RecallHealth product recall | 2023-09-15
Siemens Healthcare will be informing customers about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within the headband of the over-ear headphones listed below when used during head examinations with the Magnetom MRI…
RecallHealth product recall | 2023-09-11
Immucor, Inc. has indicated that this medical device recall is to communicate that some vials of Capture-CMV indicator red cells may contain particulates. The particulates are associated with fungal growth in the vials.
Recall Start Date: August 24,…
RecallHealth product recall | 2023-09-11
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. Insufficient securement of…
RecallHealth product recall | 2023-09-11
Arjo has observed an increasing complaint trend on the following failure modes occurring on Arjo medical beds assembled with the Indigo modules: unanticipated device self-acceleration while being operated by a caregiver, unexpected movement without any…
RecallHealth product recall | 2023-09-08
Starting in April 2023, Abbott has received complaints regarding inability of the Apical Coring Knife to start and/or complete resecting heart tissue when the physician was preparing the patient's heart for implantation of the left ventricular assist…
RecallHealth product recall | 2023-09-08
Epiphany, now a Baxter Healthcare company, is issuing an urgent medical device correction for the Cardio Server E3 ECG Management System Software due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used…
RecallHealth product recall | 2023-09-07
Masimo identified TC-I Reusable Tip Clip Sensors with higher than expected variability in spO2 readings that are outside of the accuracy specification. Masimo's investigation found the TC-I sensors had higher variability with an overall arms of 4.4%…
RecallHealth product recall | 2023-09-07
The pumps have the potential for the upstream occlusion sensor to cease proper function due to the build-up of electrostatic charge during operation triggering false downstream and upstream occlusion alarms.
Recall Start Date: August 28, 2023
RecallHealth product recall | 2023-09-07