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Terminated

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.

FDA Recall Z-0287-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGEH
Date Initiated2020-09-22
Date Terminated2021-09-22
Product Quantity1 unit

Reason for Recall

Incorrectly installed base.

Firm 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.

Root Cause

Process design

Distribution Pattern

US Nationwide distribution including in the state of Rochester, MN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGalil Medical, Inc. · 2017-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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