Company: GE Medical Systems, LLC
Date of Enforcement Report 8/24/2018
Class II:
PRODUCT
GE Healthcare MRI Systems, Software Version 11.x
Recall Number: Z-0110-2019
REASON
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI on 6/7/2018.
Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
28
DISTRIBUTION
Nationwide and Worldwide