GE Medical Systems recalls SIGNA Architect MRI systems with software versions DV26.0 to DV29.1 that may overheat implants during Low SAR Mode scans if certain imaging sequences are used. Affected units can be identified by system IDs listed 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 SIGNA Architect MRI systems with specific software versions (DV26.0 to DV29.1) because they can overheat implanted medical devices during certain scans. This risk occurs when specific imaging sequences are used in Low SAR Mode without the Optimized T2 FLAIR sequence option enabled.
The system can overheat an MR-conditional implant when scanning in Low SAR Mode using 2D FSE T2 FLAIR or T2 FLAIR Propeller sequences without the Optimized T2 FLAIR sequence option enabled. This happens because the B1+RMS value exceeds the user-set limit, potentially causing tissue damage.
MRI system users who have SIGNA Architect systems with affected software versions (DV26.0 to DV29.1) are at risk. Patients with MR-conditional implants are most vulnerable to overheating.
Check if your SIGNA Architect MRI has software versions DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, or DV29.2. System IDs listed in the recall notice (e.g., 907373MR, 2058773T) indicate affected units.
Verify your MRI system's software version by checking the system ID or software version number in the device settings.
If your system is affected, update to the latest software version that includes the fix for this issue.
No, but you should check your software version and update if affected. The recall does not require immediate discontinuation of use.
The risk involves potential overheating of MR-conditional implants during specific scans if the system is using affected software versions and certain imaging sequences without the Optimized T2 FLAIR option enabled.
Check your system ID against the list of affected units provided in the recall notice, which includes specific software versions (DV26.0 to DV29.1) and system IDs like 907373MR, 2058773T.
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-2459-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2459-2024 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.
