GE Healthcare recalls 1.5T SIGNA HDxt MRI systems with software versions HD29.1 and HD16. 2 (China only) due to potential missing slices causing anatomical gaps in 3D imaging. Affected units may require software update.
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 1.5T SIGNA HDxt MRI systems that may show gaps in 3D images due to missing slices. This could affect medical imaging accuracy for patients. The recall applies to specific software versions sold in China.
The software issue can cause some slices to be missing in 3D volume images, creating gaps in anatomical structures. This may lead to less accurate medical imaging, potentially affecting diagnosis or treatment planning. The risk is specific to certain software versions and does not involve immediate safety hazards.
Healthcare facilities using the 1.5T SIGNA HDxt MRI systems with software versions HD29.1 and HD16.2 (China only) are affected. Medical staff and patients using these systems may be at risk of inaccurate imaging results.
Check if your MRI system has software version HD29.1 or HD16.2 (China only). The recall applies to 1.5T SIGNA HDxt MRI systems.
Identify your MRI system's software version to see if it is HD29.1 or HD16.2 (China only).
The recall does not mention patient injury risks. It addresses potential inaccuracies in 3D imaging due to missing slices, which could affect diagnosis but not pose immediate safety hazards.
The recall record does not specify a fix or remedy. Affected units may need to update software, but the official notice does not state this.
The recall applies only to China for software version HD16.2.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0141-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0141-2022 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.
