Recall – MRI Software update causes errors

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.