FDAClass IINovember 4, 2020

Visual-ICE MRI Cryoablation System Mobile Connection recall

Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen…

Why was Visual-ICE MRI Cryoablation System Mobile Connection recalled?

Incorrectly installed base.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number: VM031

Product
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen…
Recalling firm
Boston Scientific Corporation
Quantity
1 unit
Distribution
US Nationwide distribution including in the state of Rochester, MN.
Recall date
November 4, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls