Z-0287-2021Class II

Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) -

Name: Z-0287-2021 Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) -
Creator: Boston Scientific Corporation
Published: 2020-09-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-09-22 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user... on 2020-09-22. FDA classified it as Class II and gives the reason as "Incorrectly installed base". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0287-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-22
Posted: 2020-10-23
Terminated: 2021-09-22
Recalling firm: Boston Scientific Corporation
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.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Incorrectly installed base.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Serial Number: VM031

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0287-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0287-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code GEH

K173037Class IIVisual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGalil Medical, Inc. / cleared 2017-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)