MR System Software Defect May Cause Implant Overheating During Scanning
GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.
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 a Class II recall involving potential implant overheating during MR scanning under specific sequence and configuration conditions. No illnesses have been reported, but the hazard presents risk of harm to patients with implants.
Plain-English summary
The recall involves GE Medical Systems SIGNA Explorer MR (magnetic resonance) imaging systems with software versions SV25.5, SV25.6, SV29.2, MR30.0, or MR30.1 distributed worldwide. During Low SAR Mode scanning, the system's predicted radiofrequency absorption rate (B1+RMS value) can exceed the user-prescribed limit under specific conditions.
The problem occurs when two conditions are both 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 device configuration. When both occur, the MR system can overheat MR-conditional implants, including pacemakers and other magnetically sensitive medical devices.
Approximately 2,528 units have been distributed. No injuries or illnesses have been reported to date. Patients with MR-conditional implants should contact their healthcare provider or GE HealthCare to determine if their system is affected and discuss appropriate next steps.
The recalled product
- Product
- SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- implant-overheating
- 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: K2308
- SHIMR02644
- 415723SHMR6
- 951682MR
- 619291MR1
- 2533
- 303355MR
- 305682MR1
- 727869MR
- 352344MR2
- 407PIMRKCH
- 630332MR
- 316689MR
- 508746JMR2
- 406863WMR
- 445MR2
- 718567MR
- 718250MR
- 716839MR1
- MSF094-1-6UQ9H2TJ
Distribution
Distribution scope not specified by the agency.
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