Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:33232
Brand Name:MRI system, full-body, superconducting magnet
Model:Multiple product names and software versions
Affected:
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:GE Healthcare Tianjin Company Ltd
Issue:The manufacturer has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met:
1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND
2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration.
If this occurs, it can result in overheating of an MR conditional implant.
You may continue to use your MR system by following the manufacturer's instructions
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:19/6/2024
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /