Reported Nov 4, 2020 · Terminated
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE
- MRI MCP) - Product UsageThe system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure
- Lot codes and dates
- Serial NumberVM031
- Amount recalled
- 1 unit
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MN
Why it was recalled
Incorrectly installed base.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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