Recall Z-1004-2023 ยท LLZ System, Image Processing, Radiological
Agfa Healthcare NV
Agfa HealthCare Enterprise Imaging XERO Viewer
| Date | Jan 20, 2023 (initiated Dec 5, 2022) |
| Status | Open, Classified |
| Reason | There is a software defect that can cause issues with images. |
| Root cause | Software design |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170434 | Enterprise Imaging XERO Viewer 8.1 Agfa Healthcare N.V., Jul 3, 2017 |