FDA recall Z-0287-2021

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

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

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