GE Medical Systems recalls SIGNA Artist MRI systems with software versions DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1 and certain model numbers due to potential overheating of MR conditional implants when scanning in Low SAR Mode with 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 Artist MRI systems with specific software versions (DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1) because they can overheat MR conditional implants during certain scans. This risk occurs when using specific imaging sequences and the Optimized T2 FLAIR sequence option is disabled.
The system can overheat MR conditional implants when scanning in Low SAR Mode and using specific imaging sequences (2D FSE T2 FLAIR or T2 FLAIR Propeller) while the Optimized T2 FLAIR sequence option is turned off or not included in the MR configuration. This overheating could cause injury to patients with implants.
MRI system users with the SIGNA Artist model and the listed software versions are affected. Patients with MR conditional implants are at higher risk due to potential overheating during specific scans.
Check if your SIGNA Artist MRI system has software versions DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, or MR30.1. The system ID numbers listed in the recall include many model-specific identifiers.
Review your MRI system's software version to see if it matches DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, or MR30.1.
Reach out to GE Medical Systems for guidance on whether your system requires a software update or other corrective action.
No, the recall does not require immediate discontinuation of use. However, you should check your software version and contact GE Medical Systems for specific instructions.
The recall states that overheating could occur during specific scans with certain imaging sequences and settings, potentially causing injury to patients with MR conditional implants.
The official recall does not specify a software update process. Contact GE Medical Systems directly for instructions on resolving the issue.
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-2469-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2469-2024 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.
