Class 2 Device Recall VisualICE MRI MCP

• Date Initiated by Firm: September 22, 2020
• Create Date: October 23, 2020
• Recall Status: Terminated 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: 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