Agfa Healthcare NV recalls

2 official recalls and safety alerts involving Agfa Healthcare NV since 2023-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Agfa Healthcare NV or the relevant agency.

1. 2024-10-16
2. US
   Drugs & medicalClass II

   Agfa Healthcare NV recalls Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and…

   Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the…

   FDA · DeviceAgfa Healthcare NVUS Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile,…Official notice →
3. 2023-02-01
4. US
   Drugs & medicalClass II

   Agfa Healthcare NV recalls Agfa HealthCare Enterprise Imaging XERO Viewer

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

   FDA · DeviceAgfa Healthcare NVDistribution throughout US OUS distribution to Australia, Belgium, Brazil,…Official notice →