Means an action taken by a manufacturer to reduce or remove a
risk of death or serious deterioration in the state of health
associated with the use of a medical device that is already placed
on the market.
The following are examples of these types of procedures:
• Checking the device to ensure that it is free from problems
• Repairing the device • Calibrating and adjusting device settings
• relabeling the device
• Destroying the device • Notifying patients about the problem of the device
