Medical Devices 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 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.

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

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

Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

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 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.

Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

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.