MRI System Software Error Can Overheat Patient Implants
GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.
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 with no reported illnesses or injuries. The hazard is potential overheating of MR-conditional implants under specific imaging conditions; no actual harm has been documented. Theoretical harm to high-risk patients (implant recipients) without reported injury is classified as High per the rubric.
Plain-English summary
GE Medical Systems recalled three SIGNA 7.0T nuclear magnetic resonance imaging systems distributed worldwide (System IDs: 319335MR1, A204479601, MR00026). The affected software versions are 7T29.1 and MR30.1.
The systems have a software defect: under Low SAR Mode, when either a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected AND the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration, the predicted B1+RMS value can exceed the user-prescribed safety limit. This failure can result in overheating of MR-conditional implants placed in patients undergoing scanning.
Healthcare facilities with these affected MRI systems should contact GE Medical Systems for remediation guidance.
The recalled product
- Product
- SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- 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 (3)
- System ID: 319335MR1
- A204479601
- MR00026
Distribution
Distribution scope not specified by the agency.
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