FDA Device recall Z-0287-2021
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a t…
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a t… by Boston Scientific, citing incorrectly installed base.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0287-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-22 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Reason
Incorrectly installed base.
Identifiers
| code_info | Serial Number: VM031 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0287-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.