Agfa Healthcare recalls XERO Viewer software versions 8.0.0 to 8.4.1 due to potential misalignment of anatomical references in medical imaging, risking misdiagnosis.
Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.
Agfa Healthcare is recalling specific versions of their XERO Viewer software used for medical imaging. The software defect can cause reference lines to be misplaced, potentially leading to incorrect diagnoses if anatomical positions are misaligned.
The software defect causes reference lines to be incorrectly placed when images have non-square pixel spacing. This misalignment could lead to misdiagnosis if the software displays anatomical locations incorrectly relative to the axial slice.
Medical professionals using the XERO Viewer software for diagnostic imaging are affected. Those using versions 8.0.0 through 8.4.1 are at risk of misdiagnosis due to incorrect anatomical reference placement.
Check if you have the XERO Viewer software version 8.0.0 through 8.4.1, including all updates and hotfixes listed in the recall notice. The software is used for reference and diagnostic viewing of medical imaging data.
Install the latest version of XERO Viewer from Agfa Healthcare's official website to fix the software defect.
No, the recall does not require immediate discontinuation. Updating to the latest version resolves the issue.
Versions 8.0.0 through 8.4.1, including all updates and hotfixes listed in the recall notice.
The defect can cause reference lines to be misplaced when images have non-square pixel spacing, potentially leading to misdiagnosis if anatomical positions are incorrectly displayed.
We’ve drafted a message you can send Agfa Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0055-2025 — Agfa Healthcare Agfa Healthcare Hello, I own a Agfa Healthcare that is covered by recall Z-0055-2025 from Agfa 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.
