---
title: "Agfa HealthCare Enterprise Imaging XERO Viewer — FDA record Z-1004-2023 | Is It on Recall"
description: "There is a software defect that can cause issues with images."
url: https://isitonrecall.com/recall/fda-device-z-1004-2023-agfa-healthcare-enterprise-imaging-xero-viewer/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Agfa HealthCare Enterprise Imaging XERO Viewer — FDA record Z-1004-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 5, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Agfa HealthCare Enterprise Imaging XERO Viewer
- **Reason**: There is a software defect that can cause issues with images.
- **Classification**: Class II
- **Recalling firm**: Agfa Healthcare NV
- **Quantity**: 110 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1004-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1004-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 1, 2023
- **Recall initiation date**: Dec 5, 2022
- **Center classification date**: Jan 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1004-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Agfa Healthcare NV records](https://isitonrecall.com/brand/agfa-healthcare-nv/)