Agfa HealthCare Enterprise Imaging XERO Viewer
- Recall Initiated
- December 5, 2022
- Posted
- January 20, 2023
- Recall Number
- Z-1004-2023
- Quantity
- 110 units
Reason for Recall
There is a software defect that can cause issues with images.
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
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.