GE SIGNA Creator MRI systems software defect risks patient implant overheating
GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.
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 for a risk-of-harm medical device with potential for implant overheating, but no illnesses or injuries have been reported.
Plain-English summary
GE Medical Systems, LLC recalled 1,817 units of SIGNA Creator MRI systems worldwide. The affected systems run software versions HD16.0_V03 through HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and MR30.1.
The issue occurs under specific conditions: when 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected in Low SAR Mode, AND the Optimized T2 FLAIR sequence option is turned off or not included in the system's configuration. Under these conditions, the system's predicted B1+RMS (radiofrequency magnetic field strength) value can exceed the user-prescribed limit.
When the B1+RMS value exceeds the prescribed limit, it can result in overheating of MR-conditional implants during scanning. Patients with medical implants that are certified as MR-compatible or MR-conditional may be at risk during MRI procedures on affected systems.
The recalled product
- Product
- SIGNA Creator, 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
- implant-overheating
- software-defect
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: 479397NUTEX
- 407PRMDMR
- 828210VETMR
- DZ3736MR01
- DZ3048MR01
- DZ3898MR01
- DZ1033MR03
- DZ2763MR01
- DZ2416MR01
- DZ1174MR01
- DZ4681MR01
- MR9988AR
- MR4790AR
- MR4652AR
- MR2498AR
- MR9874AR
- MR9143AR
- MRR10900
- MR6013AR
- MR1950AR
Distribution
Distribution scope not specified by the agency.
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