Recall Z-0287-2021 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
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.
| Date | Sep 22, 2020 |
| Status | Terminated |
| Reason | Incorrectly installed base. |
| Root cause | Process design |
| Action | On 9/22/2020 the firm sent its consignee a letter. Accounts are not asked to return the affected product to BSC. The customer notification letter will notify the affected customer that the Visual-ICE MRI MCP unit will be corrected, and accounts are asked to complete an Acknowledgment Form indicating they have received the customer notification and are scheduling the field correction activities. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution including in the state of Rochester, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical, Inc., Nov 21, 2017 |