Z-1004-2023 Class II Ongoing
FDA device recall Z-1004-2023 was initiated by Agfa Healthcare NV on Dec 5, 2022 and is designated Class II. Reason for recall: There is a software defect that can cause issues with images. The recall status is ongoing. Affected quantity: 110 units.
Recall details
- Product Type
- Devices
- Report Date
- Feb 1, 2023
- Initiation Date
- Dec 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product description
Agfa HealthCare Enterprise Imaging XERO Viewer
Reason for recall
There is a software defect that can cause issues with images.
Distribution pattern
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
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1004-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026