GE Medical Systems recalls SIGNA Premier MRI systems with software versions RX27.0-RX27.3, RX28.0, RX29.0-RX29.2, MR30.0, MR30.1. The system may overheat an MR conditional implant if specific imaging sequences and settings are used.
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 is recalling SIGNA Premier MRI systems with certain software versions. If specific imaging sequences are selected and the Optimized T2 FLAIR option is disabled, the system may overheat an MR conditional implant.
When 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR option is turned off, the system can predict a B1+RMS value exceeding the user's prescribed limit. This may cause overheating of an MR conditional implant.
MRI system users who have SIGNA Premier with affected software versions. Patients with MR conditional implants are at higher risk.
Check if your SIGNA Premier MRI has software versions RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, or MR30.1. The affected models are listed in the detailed product codes.
Verify your SIGNA Premier MRI's software version to see if it is affected.
Ensure the Optimized T2 FLAIR sequence option is enabled in your MRI settings.
Software versions RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, and MR30.1 are affected.
Check the software version on your SIGNA Premier MRI. Affected models are listed in the detailed product codes provided in the recall notice.
If you have an MR conditional implant, ensure the Optimized T2 FLAIR option is enabled when using the MRI to prevent overheating.
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-2462-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2462-2024 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.
