GE Medical Systems recalls Optima MR450w 1.5T MRI systems with software versions DV24.0 through MR30.1 that may overheat implants during Low SAR Mode scans if certain imaging sequences are selected and the Optimized T2 FLAIR sequence is disabled.
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 certain Optima MR450w 1.5T MRI systems with specific software versions (DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1) because they can cause overheating of MR-conditional implants when scanning in Low SAR Mode with specific imaging sequences and disabled Optimized T2 FLAIR settings. This risk occurs under two conditions: using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences, and having the Optimized T2 FLAIR sequence option turned off or not included in the MR configuration.
The system can predict a B1+RMS value that exceeds the user-prescribed limit when scanning in Low SAR Mode. This happens if two conditions are met: 1) the 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 cause overheating of an MR-conditional implant.
MRI system users who own or operate the Optima MR450w 1.5T with affected software versions (DV24.0 through MR30.1) are at risk. Patients with MR-conditional implants are most vulnerable to overheating if the system is used with the specified imaging sequences and settings.
Check if your Optima MR450w 1.5T MRI system has software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall notice include specific model identifiers.
Verify your MRI system's software version to see if it matches the affected versions listed: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, or MR30.1.
Ensure the Optimized T2 FLAIR sequence option is enabled in your system settings when performing scans.
No, you do not need to stop using your system immediately. However, you should check your software version and ensure the Optimized T2 FLAIR sequence option is enabled when scanning.
If you have an MR-conditional implant, you should inform your healthcare provider about this recall and ensure your MRI system settings are updated to prevent overheating.
Check your software version against the list of affected versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall notice include specific model identifiers.
We’ve drafted a message you can send GE to request your refund or repair — edit it as you like.
Subject: Recall Z-2468-2024 — GE GE Hello, I own a GE that is covered by recall Z-2468-2024 from GE. 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.
