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

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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