GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk
GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.
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: This is an FDA Class II recall for a medical device with potential to harm implant recipients through device overheating. No illnesses or injuries have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported qualify as Score 3 (High).
Plain-English summary
GE Medical Systems is recalling 308 SIGNA MR355 Nuclear Magnetic Resonance (MRI) imaging systems distributed worldwide. The affected systems run software versions SV25.5 or SV25.6.
When scanning in Low SAR Mode, the system's predicted B1+RMS (radiofrequency energy) value can exceed the user-prescribed limit if two conditions are present: (1) a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected, AND (2) the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. When this occurs, excessive radiofrequency energy can cause magnetic resonance-conditional implants—such as pacemakers, neurostimulators, and other implanted devices—to overheat.
GE Medical Systems issued this recall to alert healthcare facilities and implant patients of the risk. Facilities with affected systems should consult GE for software updates and operational guidance.
The recalled product
- Product
- SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- thermal-injury
- mri-safety
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: 082427110089
- 082427110085
- 082427040318
- 082427010165
- 082427030217
- 082427160341
- 082427190152
- 082427110096
- 82427100448
- 082427290071
- 082427160273
- 082427090359
- 082427230237
- 082427130113
- 082427130115
- 082427130130
- 082427160366
- 082427030166
- 82427210264
- 082427070299
Distribution
Distribution scope not specified by the agency.
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