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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.
Device was distributed without a proper marketing authorization.
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.