GE Medical Systems recalls Brivo MR355 MRI systems with specific software versions 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 Medical Systems is recalling Brivo MR355 MRI systems with software versions SV20.3, SV23.3, MR30.0, and MR30.1. These systems could overheat MR conditional implants if specific imaging sequences are used and the Optimized T2 FLAIR option is disabled.
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 or not included in the MR configuration. This overheating risk could affect MR conditional implants.
MRI system users who own the Brivo MR355 with affected software versions. Patients with MR conditional implants are most at risk if the system is used under the described conditions.
Check if your Brivo MR355 MRI system has software versions SV20.3, SV23.3, MR30.0, or MR30.1. The system ID list includes many specific serial numbers and model codes.
Verify your MRI system's software version to see if it matches SV20.3, SV23.3, MR30.0, or MR30.1.
Software versions SV20.3, SV23.3, MR30.0, and MR30.1.
Check your system's software version against the listed versions: SV20.3, SV23.3, MR30.0, or MR30.1.
The recall does not specify a remedy, so contact GE Medical Systems for guidance.
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-2477-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2477-2024 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.