FDA-Device2020-11-04Class II
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.
Hazard
Incorrectly installed base.
Sold states
US Nationwide distribution including in the state of Rochester, MN.
Affected count
1 unit
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0287-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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