Official recall record
Brivo MR355, NMRI system
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-01-31
- Country of alert
- China
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- GE Healthcare (China) Co., Ltd.
What the authority reported
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-01-31 · US FDA — Medical Devices
SIGNA MR355, SIGNA MR360, NMRI system - 2025-01-31 · US FDA — Medical Devices
SIGNA Creator, SIGNA Explorer, NMRI systems - 2024-11-05 · US FDA — Medical Devices
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
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