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