GE Healthcare recalls Optima MR360 MRI systems with specific software versions due to potential overheating of MR conditional implants when using certain imaging sequences in Low SAR Mode.
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 Healthcare is recalling Optima MR360 MRI systems with software versions SV20.3, SV23.3, MR30.0, and MR30.1. If these systems are used with specific imaging sequences and the Optimized T2 FLAIR option is disabled, it can cause overheating of implants that are MR conditional.
The system may predict a B1+RMS value exceeding the user's prescribed limit when scanning in Low SAR Mode. This can happen if 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR sequence option is turned off. If this occurs, it can cause overheating of implants designed for MRI use.
MRI system users who own Optima MR360 systems with the affected software versions. Patients with MR conditional implants are at higher risk if the system is used incorrectly.
Check your Optima MR360 system's software version. Affected versions are SV20.3, SV23.3, MR30.0, and MR30.1. The system ID numbers listed in the recall notice also indicate affected units.
Verify your Optima MR360 system's software version to see if it is SV20.3, SV23.3, MR30.0, or MR30.1.
Ensure the Optimized T2 FLAIR sequence option is enabled when using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences.
Software versions SV20.3, SV23.3, MR30.0, and MR30.1 are affected.
If the system predicts a B1+RMS value exceeding the user's prescribed limit during Low SAR Mode scans with specific imaging sequences and the Optimized T2 FLAIR option is disabled, it can cause overheating of MR conditional implants.
No, but you should check your software version and ensure the Optimized T2 FLAIR option is enabled when using specific imaging sequences.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2478-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2478-2024 from GE Healthcare. 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.
