GE Healthcare recalls MRI systems with software version 12.x sold under various product names. The software may not have been reinstalled after service, causing images to flip left/right and patient data mismatches. Affected units include SIGNA MR/I ECHOSPD W/ EXCITE and other models 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 version 12.x that may have image flips left/right and patient data mismatches due to software not being reinstalled after service. This could lead to incorrect medical images and patient data errors during scans.
The software version 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 images and patient data errors during scans.
Healthcare facilities using GE Healthcare MRI systems with software version 12.x are likely affected. Patients undergoing scans on these systems may experience incorrect images or data errors, but the risk is low for most users.
Check if your MRI system has software version 12.x. Affected models include SIGNA MR/I ECHOSPD W/ EXCITE, SIGNA MR/I HISPD W/ EXCITE, and other specific models listed in the recall notice. The system ID and serial numbers are provided in the recall details.
Verify your MRI system's software version. If it is 12.x, it may be affected.
The latest on-site software version may not have been reinstalled at some sites after service activities, resulting in images possibly flipped left/right and patient data mismatches.
Check your software version. If it is 12.x, contact GE Healthcare for guidance on next steps.
The recall addresses potential image flips and data mismatches, but there are no immediate risks to patients. The hazard is low risk and does not require immediate action beyond checking the software version.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0111-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0111-2019 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.
