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Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023

Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed)…

Through design and development work, Max Mobility has identified a software issue with the application. When multiple processes are running on the watch's central processing unit, the application may crash unexpectedly. If this happens, the motor on the…

Stryker has determined that the affected pad-paks may be rendered inoperable due to depleted battery cells. As a result, the affected pad-paks could potentially fail to power on the device if needed for use. Recall start date: May 3, 2023

Recall being conducted as the device does not have a medical device licence in Canada and due to design flaw. Recall start date: March 27, 2023

The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version…

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Baxter is expanding the urgent medical…

Philips Respironics has detected environmental contamination (e.g. External dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental contaminants can lead to buildup of particulate on…

The service pack (full version and delta package) NX VA20A-SP06 (VA20A-04T4) contains improvements concerning performance and stability. - image reconstruction failure solved - Petra sequence image text corrected - new LW for RCCS_2G to support new…

Hillrom (a Baxter company) is issuing an urgent medical device correction for the Pro+ Mattress to inform customers of the potential for mattress top cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).…

The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252. Recall start date: March 1, 2023

If the walker isn't being used as per original design, (e.g. if the chest pad with stem is omitted or is extended beyond capacity to allow for sufficient holding), and the screw is loose, the Pommel may fall off, potentially resulting in a fall.…

Freestyle Libre 2 Application (app) users on the Android 13 Operating System (OS), with alarms enabled, may experience situations of extended bluetooth connection loss which results in persistent signal loss conditions preventing glucose alarm function.…

Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…

It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings…