GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
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 affecting medical imaging systems with a software defect that can cause overheating of MR-conditional implants. Risk is limited to patients with implanted devices and specific imaging sequence configurations; no injuries have been reported.
Plain-English summary
GE Medical Systems recalled approximately 2,146 SIGNA 1.5T MR imaging systems distributed worldwide. These affected systems contain software versions HD16.0_V03 through HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and MR30.1.
The defect affects the system's calculation of safe radiofrequency output levels. When the system operates in Low SAR mode with either 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences, and when the Optimized T2 FLAIR option is disabled or not included in the configuration, the system may deliver radiofrequency energy that exceeds safe limits.
The specific risk is to patients with MR-conditional implanted devices. Excessive radiofrequency exposure can cause these implants to overheat. No illnesses or injuries related to this defect have been reported.
The recalled product
- Product
- 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 2,146
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.
Part of a larger recall action
This product is one of 26 recalled by GE Medical Systems, LLC 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.
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