GE SIGNA Voyager MRI systems risk implant overheating under specific configurations
GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is 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: FDA Class II recall involving a risk-of-harm product (potential implant overheating) where no illnesses, injuries, or deaths have been reported. The hazard is theoretical rather than documented, meeting the rubric criterion for a maximum score of 3.
Plain-English summary
GE HealthCare has recalled certain SIGNA Voyager MRI systems due to a software configuration issue. Under specific operating conditions, the system's predicted B1+ radiofrequency absorption value can exceed the user-prescribed limit, potentially resulting in overheating of MR conditional implants.
The problem occurs when both of these conditions are simultaneously 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 scanning in Low SAR mode with these settings, the calculated radiofrequency absorption may exceed safe limits.
The recall affects 1,522 SIGNA Voyager systems worldwide. Affected software versions include PX26.0 through PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, and MR30.1.
The recalled product
- Product
- SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- implant-overheating
- thermal-injury
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: 907373VMR
- 256SPMR2
- 870642MR
- 5340995MR11
- KRMCMR2
- SMSCIA2
- 714229MR2
- SHIMR02637
- 310358VMR
- RADNETMR664
- 559447MRVOYA3
- 559447MRVOYA2
- 559447MRVOYA1
- INSIGHTMR1397
- 626359VMR4
- INSIGHTMR1371
- ALLIANCEVOYA04
- 707431MR
- 323294VMR
- 310823VMR
Distribution
Distribution scope not specified by the agency.
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