FDA Device recall Z-1004-2023
Agfa HealthCare Enterprise Imaging XERO Viewer
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Agfa HealthCare Enterprise Imaging XERO Viewer by Agfa Healthcare Nv, citing there is a software defect that can cause issues with images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1004-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-05 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Agfa Healthcare Nv |
| Distribution | n/a |
Product
Agfa HealthCare Enterprise Imaging XERO Viewer
Reason
There is a software defect that can cause issues with images.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2023%22
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