GE Medical Systems recalls SIGNA Pioneer MRI systems with software versions PX25.0 to PX29.1 that may overheat MR conditional implants when using specific imaging sequences. Affected units can be identified by system IDs listed in the recall notice.
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 Pioneer MRI systems with certain software versions (PX25.0 to PX29.1) that may overheat MR conditional implants when scanning using specific imaging sequences. This could cause injury to patients with implants that are MR-safe but not properly configured.
The system can overheat an MR conditional implant 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 is turned off or not included in the MR configuration. This overheating could cause injury to patients with implants.
MRI system users with SIGNA Pioneer models running affected software versions (PX25.0 to PX29.1) are at risk. Patients with MR conditional implants may experience overheating if the system is used with specific imaging sequences.
Check if your SIGNA Pioneer MRI has software versions PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, or MR30.0, MR30.1. Affected units have specific system IDs listed in the recall notice.
Verify your SIGNA Pioneer MRI's software version by checking the system ID or software version listed in the recall notice.
If your software version is affected, contact GE Medical Systems to update to a safe version or follow their instructions for correction.
Software versions PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, and MR30.1 are affected.
Check your system ID against the list of affected units provided in the recall notice. Affected units have specific system IDs listed in the recall notice.
Contact GE Medical Systems to update your software to a safe version or follow their instructions for correction.
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-2460-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2460-2024 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.
