GE Healthcare recalls SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 due to potential overheating of MR conditional implants when using 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 MR380 MRI systems with software versions SV25.5 and SV25.6. If certain imaging sequences are used without the Optimized T2 FLAIR option, 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 happens if 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR sequence option is turned off. Overheating can damage MR conditional implants.
MRI system users who have SIGNA MR380 with software versions SV25.5 or SV25.6 are affected. Patients with MR conditional implants are at higher risk if the system overheats.
Check if your SIGNA MR380 MRI has software versions SV25.5 or SV25.6. System IDs listed in the recall include many 12-digit numbers starting with 082427 or 82427.
Verify your MRI's software version by checking the system ID or software version number on the device.
Contact GE Healthcare to update to a software version that resolves this issue.
No, the recall does not require immediate discontinuation. Users should check their software version and update if needed.
The risk is overheating of MR conditional implants if specific imaging sequences are used without the Optimized T2 FLAIR option.
Check if your SIGNA MR380 has software versions SV25.5 or SV25.6, using the system IDs listed in the recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2474-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2474-2024 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.
