Incorrect Medical Device Component Shipped

Issue associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers;…

An image of reduced quality due to the collection or rejection of the wrong signal frequencies.

Issue associated with device failure and malfunction when device does not display adequate results or have proper display.

The device software was found to implement an incorrect sequence of steps for a specific computation.

The device software was found to contain errors in specifying or manipulating data items.

Issue associated with user's failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. …