GE Medical Systems recalls 1.5T SIGNA HDxt MRI systems with specific software versions due to potential overheating of MR conditional implants when using certain imaging sequences. Affected units include HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and others. No remedy is specified 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 certain 1.5T SIGNA HDxt MRI systems with specific software versions. If these systems are used with certain imaging sequences and the Optimized T2 FLAIR sequence option is turned off, it can cause overheating of MR conditional implants. This recall affects specific software versions and system IDs listed in the notice.
The system may predict a B1+RMS value that exceeds the user-prescribed limit when scanning in Low SAR Mode. This occurs if specific imaging sequences (2D FSE T2 FLAIR or T2 FLAIR Propeller) are selected and the Optimized T2 FLAIR sequence option is disabled. Overheating of MR conditional implants can result from this condition.
MRI system users who own or operate the affected 1.5T SIGNA HDxt MRI systems with the listed software versions. Patients with MR conditional implants are at risk if the system is used under the described conditions.
Check if your MRI system has software versions HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall notice also indicate affected units.
Verify your MRI system's software version to see if it matches the affected versions listed in the recall.
The affected software versions are HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and MR30.1.
The risk is overheating of MR conditional implants if the system is used with specific imaging sequences and the Optimized T2 FLAIR sequence option is turned off.
The recall notice does not specify a remedy.
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-2471-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2471-2024 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.