Device product
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
Z-0287-2021
Product summary
- Event
- Event 86539
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0287-2021
Official wording
Reason: Incorrectly installed base.
Code information: Serial Number: VM031
Distribution pattern: US Nationwide distribution including in the state of Rochester, MN.
Derived failure modes
-
Unknown
Incorrectly installed base.