# FDA recall Z-0287-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-09-22.

## 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 for recall

Incorrectly installed base.

## Distribution

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

## Key facts

- **Recall number:** Z-0287-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-22
- **Report date:** 2020-11-04
- **Termination date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0287-2021

## Citation

> AI Analytics. FDA recall Z-0287-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0287-2021. Source: US FDA. Licensed CC0.

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