Agfa HealthCare Enterprise Imaging XERO Viewer
FDA Recall Z-1004-2023 · Posted 2023-01-20
Recalling FirmAgfa Healthcare NV
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2022-12-05
Product Quantity110 units
Reason for Recall
There is a software defect that can cause issues with images.
Firm Action
On December 5th, 2022, a customer letter ("Mandatory Product Correction Notification") was mailed to 40 United States of America affected consignees. The letter informed the customers about the issue and outlined the planned corrective actions. Acknowledgment, via email, that the information was received and understood was requested from
the consignees.
A Mandatory Service Bulletin was released to provide documentation to Agfa Healthcare services on how to deploy the correction for Enterprise Imaging XERO Viewer for the affected customer sites.
Agfa HealthCare Service is reaching out to the affected customers to schedule and apply appropriate software correction.
Root Cause
Software design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.