FDA-Device2023-02-01Class II
Agfa HealthCare Enterprise Imaging XERO Viewer
Agfa Healthcare NV
Hazard
There is a software defect that can cause issues with images.
Sold states
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
Affected count
110 units
Manufactured in
Septestraat 27, N/A, Mortsel, N/A, Belgium
Products
Agfa HealthCare Enterprise Imaging XERO Viewer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2023Don't want to check this manually?
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