GE Healthcare recalls MRI systems with software version 11.x due to potential image flips left/right and patient data mismatches after service activities. Affected models include 1.5T and 3.0T systems with specific serial numbers.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
GE Healthcare is recalling MRI systems with software version 11.x because some sites may have missed reinstalling the latest software after service, causing images to flip left/right and patient data mismatches. This could lead to incorrect medical diagnoses.
The software may not have been properly reinstalled after service activities, causing images to flip left/right and patient data mismatches. This could lead to incorrect medical diagnoses if the issue is not resolved.
Healthcare facilities using GE Healthcare MRI systems with software version 11.x are affected. Patients using these systems may experience incorrect imaging results if the software issue is not addressed.
Check if your MRI system has software version 11.x. Affected models include 1.5T and 3.0T systems with specific product names listed in the recall notice. Serial numbers are provided in the record.
Verify your MRI system's software version to see if it is 11.x.
Reach out to GE Healthcare for guidance on resolving the software issue.
Affected models include 1.5T and 3.0T MRI systems with specific product names listed in the recall notice, such as 1.5T CXK4 LCC MAGNET, 1.5T EXCITE, and others.
Check your system's software version; affected systems have version 11.x. Serial numbers are listed in the recall notice.
The recall addresses potential image flips and data mismatches, which could lead to incorrect diagnoses. There is no mention of physical injury risks in the 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-0110-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0110-2019 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.
