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U.S. Department of Health and Human Services

Class 2 Device Recall Xero Viewer

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 Class 2 Device Recall Xero Viewersee related information
Date Initiated by FirmDecember 05, 2022
Date PostedJanuary 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1004-2023
Recall Event ID 91357
510(K)NumberK170434 
Product Classification System, image processing, radiological - Product Code LLZ
ProductAgfa HealthCare Enterprise Imaging XERO Viewer
Code Information 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
Recalling Firm/
Manufacturer		 Agfa Healthcare NV
Septestraat 27
Mortsel Belgium
For Additional Information ContactSiebrand Forsten
519-574-3512
Manufacturer Reason
for Recall		There is a software defect that can cause issues with images.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce110 units
DistributionDistribution 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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