GE Healthcare recalls 1.5T and 3.0T SIGNA HDx, HDxt, and HDxt Mobile MRI systems due to potential image flipping left to right. Affected units have specific system IDs listed in the recall notice.
There is potential for the images to be flipped left to right.
GE Healthcare is recalling certain MRI systems that may produce images flipped left to right. This could cause misdiagnosis if the images are used for medical decisions. The recall affects specific models with unique system IDs.
The MRI system may produce images that are mirrored left to right instead of showing the correct orientation. This could lead to misdiagnosis if the images are interpreted without checking for this flip.
Medical facilities that own or use the recalled MRI systems are most at risk. Patients using these systems for imaging may see flipped images, but the risk is not immediate or life-threatening.
Check the system ID on your MRI equipment. The affected models include 1.5T and 3.0T SIGNA HDx, HDxt, and HDxt Mobile systems with specific system IDs listed in the recall notice.
Identify your MRI system's unique ID from the list provided in the recall notice to confirm if it is affected.
The recall is due to a potential issue where images produced by the MRI system may be flipped left to right, which could lead to misdiagnosis if not corrected.
No, the recall does not require immediate discontinuation of use. Affected systems can continue to be used with the understanding that images may be flipped left to right.
Check the system ID on your MRI equipment against the list of affected IDs provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0860-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0860-2022 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.
