Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00741-1
Product Name/Description GE Healthcare MRI Systems

TwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant Systems

Multiple software configurations

ARTG Number: 223115
(GE Healthcare Australia - MRI system, full-body, superconducting magnet)
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 18/06/2018
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue GE Healthcare has identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. If the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Recall Action Product Defect Correction
Recall Action Instructions GE Healthcare is advising that they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible.

GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction.

Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately.

This action has been closed out on 30/08/2019
Contact Information 1800 659 465 - GE National Call Centre