GE Medical Systems recalls SIGNA Voyager MRI systems with software versions PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1. The system may overheat an MR conditional implant when scanning in Low SAR Mode with certain imaging sequences and 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 Medical Systems is recalling SIGNA Voyager MRI systems with specific software versions (PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1) because the system can overheat an MR conditional implant when scanning in Low SAR Mode with specific imaging sequences and settings. This risk occurs if 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging is selected and the Optimized T2 FLAIR sequence option is turned off or not included in the MR configuration.
The hazard occurs when the MRI system scans in Low SAR Mode with 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences selected, and the Optimized T2 FLAIR sequence option is disabled or not included in the MR configuration. This can cause the system to exceed the user-prescribed B1+RMS value, potentially overheating an MR conditional implant.
Users of SIGNA Voyager MRI systems with the affected software versions (PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1) are at risk. Patients with MR conditional implants are most vulnerable to overheating.
Check if your SIGNA Voyager MRI has software versions PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, or MR30.1. The system ID numbers listed in the recall include many specific combinations of model and serial numbers.
Verify your SIGNA Voyager MRI's software version by checking the system settings or documentation. The affected versions are PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, and MR30.1.
Ensure that the Optimized T2 FLAIR sequence option is enabled when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences in Low SAR Mode to prevent overheating risks.
The affected software versions are PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, and MR30.1.
This can cause overheating of an MR conditional implant if the system scans in Low SAR Mode with specific imaging sequences and settings that are not properly configured.
No, but you should check your software version and ensure proper imaging settings to prevent overheating risks.
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-2470-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2470-2024 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.
