Device product
Agfa HealthCare Enterprise Imaging XERO Viewer
Z-1004-2023
Product summary
- Event
- Event 91357
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-1004-2023
Official wording
Reason: There is a software defect that can cause issues with images.
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
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
Derived failure modes
-
Device software or design
software defect