GE SIGNA MR360 MRI System Software Defect May Overheat Implants
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
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 medical device recall with potential for serious harm (overheating of MR-conditional implants). No illnesses or injuries reported. Classified as High per rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE Medical Systems has recalled certain SIGNA MR360 Nuclear Magnetic Resonance Imaging (MRI) systems due to a software defect. The affected systems have software versions SV25.5 or SV25.6, and 81 units worldwide are included in this recall.
The recalled systems can produce radiofrequency (RF) exposure levels that exceed the user-prescribed limit when operating in Low SAR Mode under specific conditions. The defect occurs when both a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected AND the Optimized T2 FLAIR sequence option is turned off or not included in the system's configuration.
If these conditions are met, the excessive RF exposure can cause overheating of MR-conditional medical implants in patients undergoing imaging scans.
This is an FDA Class II recall affecting healthcare facilities operating these specific MRI systems, particularly those scanning patients with MR-conditional implants.
The recalled product
- Product
- SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- device-malfunction
- implant-overheating
- rf-exposure
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 (20)
- System ID: 082427110087
- 082427230163
- 082427160298
- 082427070229
- 082427100384
- 082427100377
- 082427120249
- 082427080097
- 082427130131
- 082427100383
- 082427100368
- 082427160308
- 082427120270
- 082427120268
- 082427150113
- 082427150115
- 082427010174
- 082427120282
- 082427120281
- 082427120255
Distribution
Distribution scope not specified by the agency.
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