Medical Devices Recalls

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.

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.

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.

Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .

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.

Incorrect (higher) Rated Burst Pressure information printed on label.

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.

Curity All Purpose Sponges were not sterilized and distributed

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.

Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.

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.