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.
Reported: November 4, 2020 Initiated: September 22, 2020 #Z-0287-2021
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution including in the state of Rochester, MN.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 1 unit.
Why was this product recalled? ▼
Incorrectly installed base.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0287-2021.
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