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U.S. Department of Health and Human Services

Class 2 Device Recall VisualICE MRI MCP

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  Class 2 Device Recall VisualICE MRI MCP see related information
Date Initiated by Firm September 22, 2020
Create Date October 23, 2020
Recall Status1 Terminated 3 on September 22, 2021
Recall Number Z-0287-2021
Recall Event ID 86539
510(K)Number K173037  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product 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.
Code Information Serial Number: VM031
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 Incorrectly installed base.
FDA Determined
Cause 2		 Process design
Action On 9/22/2020 the firm sent its consignee a letter. Accounts are not asked to return the affected product to BSC. The customer notification letter will notify the affected customer that the Visual-ICE MRI MCP unit will be corrected, and accounts are asked to complete an Acknowledgment Form indicating they have received the customer notification and are scheduling the field correction activities.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution including in the state of Rochester, MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = Galil Medical Inc.
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