Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.