Company: Agfa Healthcare NV
Date of Enforcement Report: 1/20/2023
Class II
PRODUCT
Agfa HealthCare Enterprise Imaging XERO Viewer
Recall Number:
Z-0775-2023
REASON
There is a software defect that can cause issues with images.
RECALLING FIRM/MANUFACTURER
Agfa Healthcare NV
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
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
