Agfa Healthcare XERO Viewer Software Defect Recall: Image Issues

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Recalling firmAgfa Healthcare NVSeptestraat 27, N/A · Mortsel, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Agfa Healthcare is recalling XERO Viewer software versions 8.1.... higher due to a software defect that may cause image issues. This recall affects users who have the specified software versions and UDI/DI codes.

Why it’s dangerous

The software defect can cause issues with images, potentially affecting the accuracy of medical imaging results. This may lead to incorrect diagnoses or treatment decisions if the images are not properly displayed.

Who’s affected

Users of Agfa Healthcare XERO Viewer software versions 8.1.4.100 or higher, 8.2.0.000 or higher, and 8.2.1.000 or higher are affected. Medical professionals using this imaging software are most at risk.

How to tell if you have this one

Check if your XERO Viewer software version is 8.1.4.100 or higher, 8.2.0.000 or higher, or 8.2.1.000 or higher. The UDI/DI code 05400874000710 is also associated with this recall.

Brand
Agfa Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your XERO Viewer software version to see if it matches the affected versions listed in the recall.

✎ GovInfoNow

Questions people ask

What software versions are affected by this recall?

Affected software versions include XERO Viewer 8.1.4.100 or higher, XERO Viewer 8.2.0.000 or higher, and XERO Viewer 8.2.1.000 or higher.

How can I check if my XERO Viewer is affected?

Check your software version and UDI/DI code; the recall affects units with the specific software versions and UDI/DI code 05400874000710.

What should I do if I have the affected software?

The recall does not specify a remedy, so you should check with Agfa Healthcare for further instructions.

Take action

Contact Agfa Healthcare

We’ve drafted a message you can send Agfa Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1004-2023 — Agfa Healthcare Agfa Healthcare

Hello,

I own a Agfa Healthcare that is covered by recall Z-1004-2023 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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Where this comes from

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.

Official source: FDA Recall #Z-1004-2023 (December 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1004-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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