GE recalls SIGNA Prime MRI systems with software version MR30.1 due to potential overheating of MR-conditional implants when using certain imaging sequences and disabled Optimized T2 FLAIR options.
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 is recalling SIGNA Prime MRI systems with software version MR30.1 because specific imaging settings can cause overheating of medical implants. This risk only occurs under two conditions: using certain 2D FSE T2 FLAIR sequences and having the Optimized T2 FLAIR option disabled. Affected units may need to be checked by a healthcare provider.
The system can predict a B1+RMS value that exceeds the user-set limit when scanning in Low SAR Mode. This happens only if two conditions are met: 1) a specific 2D FSE T2 FLAIR or T2 FLAIR Propeller 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 cause overheating of implants that are normally safe under MRI conditions.
Healthcare providers using SIGNA Prime MRI systems with software version MR30.1 are most at risk, particularly when scanning patients with MR-conditional implants.
Check if your SIGNA Prime MRI has software version MR30.1. Affected units have specific system IDs listed in the recall notice, including model numbers like DZ2423MR01 and MR6345AR.
Verify your SIGNA Prime MRI's software version is MR30.1 by checking the system ID on the device.
If you have an MR-conditional implant, consult your healthcare provider to determine if your scan settings pose a risk.
GE HealthCare has identified that certain SIGNA Prime MRI systems with software version MR30.1 can cause overheating of MR-conditional implants when specific imaging sequences and disabled Optimized T2 FLAIR options are used.
Check your software version and system ID. If you have an MR-conditional implant, contact your healthcare provider to assess if your scan settings pose a risk.
Affected units have software version MR30.1 and specific system IDs listed in the recall notice, including model numbers like DZ2423MR01 and MR6345AR.
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-2479-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2479-2024 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.
