GE Medical Systems recalls SIGNA PET/MR systems with specific software versions (MP24.0, MP26.0, etc.) due to potential overheating of MR conditional implants during low SAR mode scans.
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 PET/MR MRI systems with certain software versions. The issue could cause overheating of medical implants during specific imaging sequences, potentially leading to injury.
When scanning in Low SAR Mode with specific imaging sequences (2D FSE T2 FLAIR or T2 FLAIR Propeller) and the Optimized T2 FLAIR sequence option disabled, the system may predict a B1+RMS value exceeding the user's set limit. This can cause overheating of implants designed for MRI safety.
Patients using SIGNA PET/MR systems with affected software versions (listed in the recall) and individuals who scan patients with these systems. Those with MR conditional implants are at higher risk.
Check your SIGNA PET/MR system's software version. Affected versions include MP24.0, MP26.0, MP26.1, MR30.0, MR30.1. System IDs are listed in the recall notice.
Review your SIGNA PET/MR 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 is affected and next steps.
Affected software versions include MP24.0, MP26.0, MP26.1, MR30.0, and MR30.1.
The system may overheat MR conditional implants during specific scans in Low SAR Mode if the Optimized T2 FLAIR sequence option is disabled.
No. The recall requires checking software versions and contacting GE Medical Systems for guidance.
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-2466-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2466-2024 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.
