GE Medical Systems recalls SIGNA 7.0T MRI systems with software versions 7T29.1 and MR30.1 due to potential overheating of MR conditional implants when using specific imaging sequences.
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 SIGNA 7.0T MRI systems with software versions 7T29.1 and MR30.1. These systems could overheat an MR conditional implant if specific imaging sequences are used in Low SAR Mode without the Optimized T2 FLAIR sequence option enabled.
The system may predict a B1+RMS value that exceeds the user's set limit when scanning in Low SAR Mode. This happens if 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are selected and the Optimized T2 FLAIR sequence option is disabled. Overheating of an MR conditional implant could result.
MRI system users who have SIGNA 7.0T systems with software versions 7T29.1 or MR30.1 are affected. Patients with MR conditional implants are at risk if the system is used with the specified imaging sequences.
Check for SIGNA 7.0T MRI systems with software versions 7T29.1 or MR30.1. The system ID numbers listed are 319335MR1, A204479601, and MR00026.
Verify your SIGNA 7.0T system's software version to see if it is 7T29.1 or MR30.1.
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the user prescribed limit when scanning in Low SAR Mode with specific imaging sequences and disabled Optimized T2 FLAIR sequence option.
The recall record does not specify a remedy, so no action is required at this time.
The recall states it could result in overheating of an MR conditional implant, but no specific injury mechanism is described.
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-2483-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2483-2024 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.
