All Recalls

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

The product is contaminated with Pseudomonas.

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.

Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.