GE SIGNA Premier MRI system software overheating risk to implants
GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating 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: This is FDA Class II recall of an MRI system with a software defect that can cause radiofrequency energy to exceed prescribed safety limits under specific imaging sequence conditions, potentially resulting in overheating of MR-conditional implants. No illnesses or injuries have been reported, placing this at the High level per the rubric criterion for risk-of-harm products without reported injuries.
Plain-English summary
GE Medical Systems, LLC is recalling 404 SIGNA Premier MRI systems worldwide. The affected systems contain software versions RX27.0 through RX27.3, RX28.0, RX29.0 through RX29.2, MR30.0, and MR30.1.
The issue occurs when two specific conditions are met simultaneously: a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected, and the Optimized T2 FLAIR sequence option is either turned off or not included in the system configuration. Under these conditions, the system's predicted B1+RMS radiofrequency energy value can exceed the user-prescribed safety limit when operating in Low SAR Mode.
Excessive radiofrequency energy exposure can result in overheating of MR-conditional medical implants, such as pacemakers and neurostimulators, which could lead to device malfunction. No illnesses or injuries have been reported in connection with this issue.
Healthcare facilities with affected systems should contact GE Medical Systems, LLC for information regarding this recall.
The recalled product
- Product
- SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- excessive-rf-energy
- implant-overheating
- device-malfunction
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)
- 205934MR1
- 205750MR2
- 205345MR3T
- SMIROMEPREMMR1
- SMIGDYPREMMR1
- 602830MR3
- 602406MR6
- 520UNCMR1
- 510STPRMR
- 858657MR6
- 858657MR5
- 858657MR4
- 858657HDMR3
- 661949MR3T
- 510MIA3T
- 415723CHMR7
- 415493VMR3
- 415723SHMR17
- 415723SHMR14
- 650723SSMR2
Distribution
Distribution scope not specified by the agency.
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