GE Healthcare recalls SIGNA Hero MRI systems with specific software versions due to overheating risk when using certain imaging sequences. Affected units may cause harm to MR conditional implants.
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 Hero MRI systems with software versions PX29.1, MR30.0, and MR30.1. These systems could overheat an MR conditional implant if specific imaging sequences are used in Low SAR Mode without the Optimized T2 FLAIR sequence option enabled.
When scanning in Low SAR Mode with 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences selected and the Optimized T2 FLAIR sequence option disabled, the system may predict a B1+RMS value exceeding the user's prescribed limit. This can cause overheating of MR conditional implants.
MRI system users who have the SIGNA Hero MRI with affected software versions are at risk. Patients with MR conditional implants are most vulnerable to overheating.
Check if your SIGNA Hero MRI has software versions PX29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall notice include specific combinations like 501225HEROMR3, 480425MR12, and others.
Review your MRI system's software version to see if it matches PX29.1, MR30.0, or MR30.1.
Reach out to your MRI facility or GE Healthcare for guidance on whether your system requires correction.
Software versions PX29.1, MR30.0, and MR30.1 are affected.
Check if your system has software versions PX29.1, MR30.0, or MR30.1, or if your system ID matches the listed numbers like 501225HEROMR3 or 480425MR12.
No, but you should check your software version and contact your provider to determine if your system requires correction.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2461-2024 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.
