Home / Recalls / Medical Devices
Agfa Healthcare NV recalls Agfa HealthCare Enterprise Imaging XERO Viewer
Recalled February 1, 2023 · FDA recall Z-1004-2023 · Agfa Healthcare NV
Hazard
There is a software defect that can cause issues with images. · FDA Class II
Units
110 units
Sold at
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
Description
There is a software defect that can cause issues with images.
Product
Agfa HealthCare Enterprise Imaging XERO Viewer
Manufacturer(s)
Agfa Healthcare NV
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →