FDA Recall
Terminated
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.
Recall: Z-0287-2021
·
Initiated September 22, 2020
Recall
- Recall Number
- Z-0287-2021
- Event Number
- 86539
- Firm
- Boston Scientific Corporation
- FEI Number
- 3005099803
- Product Code
- GEH
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- September 22, 2020
- Terminated
- September 22, 2021
- Address
- 300 Boston Scientific Way, Marlborough, MA, 01752-1291
Description
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.
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.
Distribution
US Nationwide distribution including in the state of Rochester, MN.
Quantity
1 unit