Other Medical Devices

No 510k for the product to be used in a natural or surgical opening to the body

No 510k for the product to be used in a natural or surgical opening to the body

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

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

No 510k for the product to be used in a natural or surgical opening to the body

No 510k for the product to be used in a natural or surgical opening to the body

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.

No 510k for the product to be used in a natural or surgical opening to the body

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.

No 510k for the product to be used in a natural or surgical opening to the body

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.

No 510k for the product to be used in a natural or surgical opening to the body

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.

No 510k for the product to be used in a natural or surgical opening to the body

No 510k for the product to be used in a natural or surgical opening to the body

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.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.