Recall Z-0287-2021— Boston Scientific Corporation

Name: FDA recall Z-0287-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-22

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-09-22, terminated 2021-09-22. It names one FDA 510(k) clearance: K173037. 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.. Reason: Incorrectly installed base..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-09-22
Terminated: 2021-09-22
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGalil Medical, Inc.·cleared 2017-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Incorrectly installed base.

Data sourced from openFDA. This site is unofficial and independent of the FDA.