Agfa Healthcare NV Septestraat 27 Mortsel Belgium Agfa HealthCare Enterprise Imaging XERO Viewer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Agfa HealthCare Enterprise Imaging XERO Viewer
Brand
Agfa Healthcare NV Septestraat 27 Mortsel Belgium
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710
Agfa Healthcare NV Septestraat 27 Mortsel Belgium is recalling Agfa HealthCare Enterprise Imaging XERO Viewer due to There is a software defect that can cause issues with images.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a software defect that can cause issues with images.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026