GE Medical Systems recalls SIGNA Creator MRI systems with software versions HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1 due to potential overheating of MR conditional implants during Low SAR Mode scans with specific imaging sequences.
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 Creator MRI systems with certain software versions (HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1) because they can overheat MR conditional implants when scanning in Low SAR Mode with specific imaging sequences. This risk could cause injury to patients with implants.
The system can predict a B1+RMS value that exceeds the user-prescribed limit when scanning in Low SAR Mode. This occurs if both 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR sequence option is turned off or not included in the MR configuration. This can cause overheating of MR conditional implants.
Owners of SIGNA Creator MRI systems with the listed software versions are at risk. Patients with MR conditional implants are most vulnerable during specific imaging sequences.
Check if your SIGNA Creator MRI has software versions HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall are also unique identifiers for affected units.
Review your MRI system's software version to see if it matches the affected versions listed in the recall.
Reach out to GE Medical Systems for guidance on whether your system requires correction or if it is safe to use.
The affected software versions are HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and MR30.1.
The risk is overheating of MR conditional implants during Low SAR Mode scans with specific imaging sequences, which could cause injury.
No, but you should check your software version and contact GE Medical Systems for specific guidance on safe use.
We’ve drafted a message you can send GE to request your refund or repair — edit it as you like.
Subject: Recall Z-2472-2024 — GE GE Hello, I own a GE that is covered by recall Z-2472-2024 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.
