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Olympus found that certain lots of the CV-190 do not start up properly and as a result, the image from the endoscope is not displayed when the operations listed below are performed because parts that deviated from the specification were assembled into…

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…

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…

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…

On 05/05/2023 customer in lab in Switzerland identified that two Multichem® S Plus vials were cracked at the bottom and material was leaking from the vial. No actual end-user/patient harm was identified as a result of the cracked vial. Recall start…

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…

The shaft and tip component of the Universal Joint Screwdriver was manufactured with the incorrect raw stainless steel material. Recall start date: September 1, 2023

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…

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.…

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…

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…

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,…

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…

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life. It has been confirmed that Stryker's distribution…

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…