GE Medical Systems recalls SIGNA UHP MRI research systems with RX28.0 or MR30.1 software versions due to potential overheating of MR-conditional implants when using 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 UHP MRI systems with RX28.0 or MR30.1 software versions for research use. The recall is because these systems could overheat MR-conditional implants if certain imaging sequences are used without the Optimized T2 FLAIR option enabled.
The system may predict a B1+RMS value that exceeds the user's set limit when scanning in Low SAR Mode. This happens if 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. Overheating could affect MR-conditional implants.
Researchers using SIGNA UHP MRI systems with RX28.0 or MR30.1 software versions are most at risk. The affected systems are identified by specific system IDs listed in the recall notice.
Check if your SIGNA UHP MRI system has software versions RX28.0 or MR30.1. Affected systems include those with specific system IDs: 650723PSYMR, 919684BIAC6, 919684MR5, 403944MR1, 082427040271, 082427040289.
Verify your SIGNA UHP MRI system's software version to see if it is RX28.0 or MR30.1.
The system may predict a B1+RMS value that exceeds the user's set limit when scanning in Low SAR Mode with specific imaging sequences and disabled Optimized T2 FLAIR option, potentially causing overheating of MR-conditional implants.
Software versions RX28.0 and MR30.1 for SIGNA UHP MRI systems used in research.
Check your system ID against the list: 650723PSYMR, 919684BIAC6, 919684MR5, 403944MR1, 082427040271, 082427040289.
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-2481-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2481-2024 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.
