Inadequate Medical Device Service

Issue associated with the insufficient removal of unwanted visible soil, foreign material or organism deposits on the external surfaces, crevices, joints of…

Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to…

Issue associate with facility not providing satisfactory initial and/or periodic user training covering operation of the device.

Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package…

A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI).

Issue associated with the means by which the operator and the equipment communicate or interact.