GE Medical Systems recalls SIGNA MAGNUS MRI research systems with software versions MR29.1 or RX29.1 due to overheating risk when specific imaging sequences are used in Low SAR Mode.
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 Medical Systems recalls SIGNA MAGNUS MRI research systems with software versions MR29.1 or RX29.1. The system may overheat an MR conditional implant if certain imaging sequences are used in Low SAR Mode without the Optimized T2 FLAIR sequence option enabled.
When 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected in Low SAR Mode and the Optimized T2 FLAIR sequence option is disabled, the system may predict a B1+RMS value exceeding the user's set limit. This can cause overheating of MR conditional implants.
Researchers using SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1 for research purposes are most at risk. The hazard affects only specific imaging sequences and configurations.
Check for SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. These are research-only systems with System ID 608BUCKYS3T.
Verify your SIGNA MAGNUS MRI system's software version by checking the system ID or software menu.
Ensure the Optimized T2 FLAIR sequence option is enabled when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences in Low SAR Mode.
Software versions MR29.1 and RX29.1.
No, this recall applies only to research use systems.
Check for SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1, which are research-only systems with System ID 608BUCKYS3T.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2484-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2484-2024 from GE Medical Systems. 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.
