—#183954

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.

FDA product code: GEH — Unit, Cryosurgical, Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K173037
Affected lot / code info: Serial Number: VM031

Why it was recalled

Incorrectly installed base.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

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

Timeline

Recall initiated: 2020-09-22
Terminated: 2021-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.