MRI Systems May Resume Scans When SAR Exceeds Safe Limits
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
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 FDA Class II medical device recall with no reported injuries or illnesses, but the hazard—excessive radiofrequency energy absorption causing potential tissue heating—represents a clear risk of harm. The recall meets the High criteria as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 241 SIGNA MR355 and SIGNA MR360 MRI systems due to a user interface issue affecting scan safety protocols. When a Power Monitor alarm stops a scan, the system may incorrectly allow the scan to resume even though the average radiofrequency energy absorption—measured as Specific Absorption Rate (SAR)—exceeds the FDA safety limits displayed on the SAR Display. This creates a risk of excessive tissue heating.
The issue affects patients undergoing MRI scans on these recalled systems, particularly those with metallic implants or in contact with conductive materials during the scan. Excessive tissue heating from exceeding SAR limits could cause burns or other thermal injuries.
Healthcare facilities with these MRI systems should verify whether their equipment is included in this recall using the system identification numbers listed by GE Healthcare. Facilities should contact GE Healthcare to obtain remediation steps to address this safety issue.
The recalled product
- Product
- SIGNA MR355, SIGNA MR360, NMRI system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 241
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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- HighGE Healthcare MRI system recalled for RF energy safety control failure
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- HighGE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
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- ModerateGE Healthcare Revolution Frontier CT systems may produce rotated images during scans
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Same hazard · excessive sar
See all →- HighGE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error
FDA (Devices) · 2015-11-18
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