GE Healthcare MRI system recalled for RF energy safety control failure
GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.
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: This is a risk-of-harm medical device with a failure to enforce RF energy safety limits, allowing potential excessive tissue heating. No injuries or illnesses have been reported, placing it at the High level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare (China) Co., Ltd. is recalling 33 Optima MR360 NMRI systems. These systems are distributed domestically throughout the United States and internationally worldwide.
The systems have a software issue where a scan can resume following a Power Monitor trip even when the 6-minute average SAR (Specific Absorption Rate) exceeds the safety limit displayed in the user interface. The user interface may incorrectly enable a scan to proceed earlier than intended.
If resumed under these conditions, 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.
The recalled product
- Product
- Optima MR360, NMRI system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)
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.
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