🏥 Medical Devices • 6,554 recalls
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
GE Healthcare
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
BioFire Diagnostics
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Siemens Healthcare Diagnostics
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
Radiometer Medical ApS
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Abbott Laboratories Inc. (St Jude Medical)
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Skytron, Div. The KMW Group
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
Radiometer Medical ApS
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Abbott Laboratories Inc. (St Jude Medical)
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
INNOVA MEDICAL GROUP
Due to distributing test kits to customers who were not part of a clinical investigation.
INNOVA MEDICAL GROUP
Due to distributing test kits to customers who were not part of a clinical investigation.
Philips North America
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
Display of potential patient movement might be delayed to the user for high dose treatments.
Philips North America
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
INNOVA MEDICAL GROUP
Due to distributing test kits to customers who were not part of a clinical investigation.
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages