Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 12/29/2018
Class II

PRODUCT

GE Magnetic Resonance System

Various GE Magnetic Resonance System on-site software version. Product Usage: Magnetic resonance imaging equipment for general diagnostic use.

Recall Number: Z-0693-2019

REASON

Possible incorrect software version loaded.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC, Waukesha, WI on 11/15/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,849

DISTRIBUTION
Nationwide and Internationally