GE Medical Systems recalls certain SIGNA HDxt 3.0T MRI systems with software versions RX27.0-RX27.3, RX28.0, RX29.0-RX29.2, and MR30.0 that may overheat MR-conditional implants during 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 certain SIGNA HDxt 3.0T MRI systems with specific software versions. If the system is used with certain imaging sequences and the Optimized T2 FLAIR option is disabled, it can cause overheating of MR-conditional implants.
The system may predict a B1+RMS value that exceeds the user's prescribed limit when scanning in Low SAR Mode. This occurs only if 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 happens, it can cause overheating of an MR-conditional implant.
MRI system users with the recalled software versions are at risk. Patients with MR-conditional implants may experience overheating if the system is used with specific imaging sequences and the Optimized T2 FLAIR option is disabled.
Check if your SIGNA HDxt 3.0T MRI system has software versions RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, or MR30.0. The system ID numbers listed in the recall notice also identify affected units.
Verify your MRI system's software version to see if it matches the recalled versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, or MR30.0.
Ensure the Optimized T2 FLAIR sequence option is enabled when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences.
Software versions RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, and MR30.0 are affected.
Check if the Optimized T2 FLAIR sequence option is enabled when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences to prevent overheating of MR-conditional implants.
The recall states that overheating of an MR-conditional implant can occur, but it does not specify that this will cause serious injury in normal use.
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-2463-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2463-2024 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.
