# FDA recall Z-1004-2023

> **Agfa Healthcare NV** · Class II · device recall initiated 2022-12-05.

## Product

Agfa HealthCare Enterprise Imaging XERO Viewer

## Reason for recall

There is a software defect that can cause issues with images.

## 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

## Key facts

- **Recall number:** Z-1004-2023
- **Recalling firm:** Agfa Healthcare NV
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-05
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mortsel, N/A, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2023

## Citation

> AI Analytics. FDA recall Z-1004-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1004-2023. Source: US FDA. Licensed CC0.

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