MRI System May Resume Scanning Above Safe Thermal Limits
GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard—excessive tissue heating from magnetic field exposure—is serious and credible but remains theoretical. Per the rubric, recalls without reported harm and with theoretical risk score at most 3 (High).
Plain-English summary
GE Healthcare's Brivo MR355 NMRI system is subject to a Class II recall due to a software flaw in its scan safety controls. When a Power Monitor trip occurs, the system may incorrectly allow operators to resume scanning even when the "6-minute average SAR" (Specific Absorption Rate) exceeds the safety limit shown on the SAR Display.
If a scan is resumed under these conditions, the magnetic field can cause excessive tissue heating in the patient. This risk is particularly acute if the patient is in contact with conductive materials or has metallic implants, which can concentrate heat and increase the potential for serious thermal injury.
This recall affects 22 Brivo MR355 systems that were distributed domestically throughout the United States and internationally.
The recalled product
- Product
- Brivo MR355, NMRI system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- tissue-heating
- burn-injury
- control-failure
Distribution
Distributed nationwide across the United States.
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