GE Healthcare recalls SIGNA Premier MRI systems with specific software versions (RX29.1 and RX27.3) sold in China due to potential missing slices causing anatomical gaps in 3D imaging. Affected units may require software updates.
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 Premier MRI systems sold in China with specific software versions. Missing slices in 3D imaging could create gaps in anatomical views, potentially affecting diagnostic accuracy.
The software issue causes some slices to be missing during 3D volume imaging, creating gaps in anatomical structures. This could lead to less precise diagnostic images, but does not cause physical harm or immediate safety risks.
Medical facilities using SIGNA Premier MRI systems with software versions RX29.1 or RX27.3 (sold in China) are most at risk. Patients undergoing scans on these systems may experience less accurate imaging.
Check if your SIGNA Premier MRI system has software versions RX29.1 or RX27.3, which were sold in China. The recall applies only to these specific software versions.
Verify your MRI system's software version to see if it matches RX29.1 or RX27.3 (sold in China).
The recall is due to a software issue that can cause missing slices in 3D volume images, potentially leading to gaps in anatomical views.
The official notice does not specify a fix or remedy for this recall.
Software versions RX29.1 and RX27.3 (sold in China) are affected by this recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0132-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0132-2022 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.