Medical Device Shelf Life Exceeded

Issue associated with the lack of periodic preventive maintenance or performance assurance checks.

Issue associated with device features that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) that do not…

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range from small…

Issue associated with drawing back the device and/or device component to an intended location.

Issue associated with setting a variable, register, or other storage location back to a prescribed state.

Issue associated with any deviations from device documented performance specifications relating to the implemented and inherited design features specific to devices used…