GE recalls SIGNA MR355 MRI systems with software versions SV25.5 and SV25.6 due to potential overheating of MR-conditional implants when using specific imaging sequences and disabled Optimized T2 FLAIR settings.
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 is recalling SIGNA MR355 MRI systems with software versions SV25.5 and SV25.6. If certain imaging sequences are used without the Optimized T2 FLAIR option enabled, the system may overheat an MR-conditional implant, posing a risk to patients with such implants.
The system can overheat an MR-conditional implant when scanning using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences and the Optimized T2 FLAIR sequence option is disabled. This overheating could cause harm to patients with implants that are designed to be safe during MRI scans.
Patients with MR-conditional implants who use the SIGNA MR355 MRI system with affected software versions SV25.5 or SV25.6 are most at risk. The recall affects specific models sold in the U.S. between 2018 and 2023.
Check if your SIGNA MR355 MRI system has software versions SV25.5 or SV25.6. The system ID numbers listed in the recall include many specific combinations of numbers and letters.
Verify your system's software version by checking the system ID or software version number on the device.
Reach out to GE Medical Systems directly for specific instructions on whether your system is affected and what actions to take.
The recall does not require stopping use immediately. Patients with MR-conditional implants should check if their system is affected and follow GE's guidance.
Software versions SV25.5 and SV25.6 are affected.
Check the system ID listed in the recall, which includes specific combinations of numbers and letters. The affected systems have software versions SV25.5 or SV25.6.
We’ve drafted a message you can send GE to request your refund or repair — edit it as you like.
Subject: Recall Z-2475-2024 — GE GE Hello, I own a GE that is covered by recall Z-2475-2024 from GE. 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.
