Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:20650
Brand Name:MRI system, full-body, superconducting magnet
Model:
Affected:SIGNA Creator and SIGNA Explorer
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 of an issue with incorrect RF Power Monitor Function with the Signa Creator and Signa Explorer.
If the RF amplifier output power exceeds the predicted SAR (Specific Absorption Rate) amount, the RF power monitor will stop the scan. This would prevent the power monitor from detecting any subsequent failure of RF transmit function.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:19/9/2016
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