Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
All Recalls
92,900 total recalls in our database
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Stryker Communications
🏥 Medical Devices Class I - Dangerous
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
🏥 Medical Devices Class I - Dangerous
One lot manufactured with an invalid sterilization cycle.
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
🏥 Medical Devices Class I - Dangerous
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
🏥 Medical Devices Class I - Dangerous
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Potential for activation of an abnormal alarm pause.
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Philips North America
🏥 Medical Devices Class I - Dangerous
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
🏥 Medical Devices Class I - Dangerous
One lot manufactured with an invalid sterilization cycle.