GE Healthcare recalls SIGNA Architect MRI systems with software versions DV29.1, DV28.4 (F), and DV27.3 (T) for potential missing slices causing anatomical gaps in 3D imaging. Affected units sold in China only.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
GE Healthcare is recalling certain SIGNA Architect MRI systems that may show missing slices in 3D images, creating gaps in anatomical views. This could lead to inaccurate diagnoses if the issue isn:3D imaging is used for medical procedures.
The software issue causes some slices to be missing during 3D imaging, creating gaps in anatomical views. This could result in incomplete or inaccurate medical images that might affect diagnosis decisions.
Medical facilities using SIGNA Architect MRI systems with specific software versions sold in China are most at risk. Patients undergoing scans on these systems may receive less accurate images.
Check if your SIGNA Architect MRI system has software version DV29.1, DV28.4 (F), or DV27.3 (T). These versions were sold in China only.
Identify your MRI system's software version to see if it matches DV29.1, DV28.4 (F), or DV27.3 (T).
The software issue causes some slices to be missing during 3D imaging, creating gaps in anatomical views that could affect diagnosis accuracy.
Check if your SIGNA Architect MRI system has software version DV29.1, DV28.4 (F), or DV27.3 (T), which were sold in China only.
The recall does not specify a remedy, so contact GE Healthcare directly for guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0133-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0133-2022 from GE Healthcare. 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.
