GE Healthcare is recalling MRI systems with software versions 15.x or HD 16 that may show flipped left/right images and patient data mismatches after service activities. Affected models include ER15T HDXT and others listed in the recall notice.
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 versions 15.x or HD 16 that may show flipped left/right images and patient data mismatches after service activities. This could lead to incorrect medical diagnoses if not addressed.
The software may not have been properly reinstalled after service activities, causing images to be flipped left/right and patient data to mismatch. This could lead to incorrect medical diagnoses if the issue is not resolved.
Healthcare facilities that own or use GE Healthcare MRI systems with software versions 15.x or HD 16 are affected. Patients using these systems may experience incorrect imaging results if the software issue is not corrected.
Check if your MRI system has software version 15.x or HD 16. Affected models include ER15T HDXT, 1.5T HDX, and other specific product names listed in the recall notice. The recall includes serial numbers and model numbers provided in the notice.
Verify your MRI system's software version to see if it is 15.x or HD 16.
Reach out to GE Healthcare for guidance on correcting the software issue.
Software versions 15.x or HD 16.
Images may be flipped left/right and patient data may mismatch, potentially leading to incorrect medical diagnoses.
No, but you should check the software version and contact GE Healthcare to correct the issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0112-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0112-2019 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.
