Medical device recalls

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.

New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

There is a potential for weak seals of the sterile packaging.

There is a potential for weak seals of the sterile packaging.

There is a potential for weak seals of the sterile packaging.

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

There is a potential for the device to fail to deliver energy to the patient.

When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

This product has been contaminated with Stenotrophomonas lactiubi.

This product has been contaminated with Stenotrophomonas lactiubi.

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.