Z-0287-2021 Class II Terminated
FDA device recall Z-0287-2021 was initiated by Boston Scientific Corporation on September 22, 2020 and is designated Class II. Reason for recall: Incorrectly installed base. The recall status is terminated (terminated September 22, 2021). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 22, 2020
- Termination Date
- September 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product 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 for Recall
Incorrectly installed base.
Distribution Pattern
US Nationwide distribution including in the state of Rochester, MN.
Code Information
Serial Number: VM031