GE Healthcare recalls SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 due to potential overheating of MR conditional implants during specific imaging sequences.
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 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 MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
GE Healthcare is recalling SIGNA MR360 MRI systems with software versions SV25.5 and SV25.6. If certain imaging sequences are used in Low SAR Mode without the Optimized T2 FLAIR sequence option enabled, the system may overheat an MR conditional implant.
The system can predict a B1+RMS value that exceeds the user's prescribed limit when scanning in Low SAR Mode. This occurs if 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR sequence option is turned off or not included in the MR configuration. Overheating of an MR conditional implant could then occur.
MRI system users with SIGNA MR360 models running software versions SV25.5 or SV25.6 are affected. Patients with MR conditional implants are at risk if the specific imaging conditions are met.
Check if your SIGNA MR360 MRI system has software versions SV25.5 or SV25.6. The system ID numbers listed in the recall notice indicate affected units.
Review your MRI system's software version to see if it is SV25.5 or SV25.6.
GE Healthcare has identified that certain MRI systems with specific software versions may overheat an MR conditional implant under specific imaging conditions.
Check your software version. If it is SV25.5 or SV25.6, contact GE Healthcare for guidance on potential fixes or updates.
The recall indicates a potential overheating risk for MR conditional implants, but no specific injuries have been reported. The risk is low and depends on specific imaging conditions.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2476-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2476-2024 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
