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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare (China) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · GE Healthcare (China) Co., Ltd.
See all →- HighMRI Systems May Resume Scans When SAR Exceeds Safe Limits
FDA (Devices) · 2025-03-05
- HighMRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits
FDA (Devices) · 2025-03-05
- HighGE Healthcare MRI system recalled for RF energy safety control failure
FDA (Devices) · 2025-03-05
- HighGE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
FDA (Devices) · 2025-03-05
- ModerateGE Healthcare Revolution Frontier CT systems may produce rotated images during scans
FDA (Devices) · 2024-12-11
Similar recalls
- HighGE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk
FDA (Devices) · 2024-08-14
- HighGE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring
FDA (Devices) · 2017-08-23
- SevereGE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk
FDA (Devices) · 2017-02-22
- HighGE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk
FDA (Devices) · 2024-08-14
- HighGE SIGNA MR360 MRI System Software Defect May Overheat Implants
FDA (Devices) · 2024-08-14
- HighGE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation
FDA (Devices) · 2022-02-16