Medical equipment, implants, and diagnostic devices
Philips Medical Systems Nederlands
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
BioFire Diagnostics
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Exact Medical Manufacturing
No 510k for the product to be used in a natural or surgical opening to the body
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Exact Medical Manufacturing
No 510k for the product to be used in a natural or surgical opening to the body
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Exact Medical Manufacturing
No 510k for the product to be used in a natural or surgical opening to the body
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Exact Medical Manufacturing
No 510k for the product to be used in a natural or surgical opening to the body
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, 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.
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Exact Medical Manufacturing
No 510k for the product to be used in a natural or surgical opening to the body
Cardinal Health
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, 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 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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.