Agfa HealthCare Enterprise Imaging XERO Viewer recallZ-1004-2023 · Agfa Healthcare NV · initiated Dec 5, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Agfa Healthcare NV or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a software defect that can cause issues with images.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1004-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2022
- Posted by the FDA
- Jan 20, 2023
- Recalling firm
- Agfa Healthcare NV
- Quantity
- 110 units
- Product code
- LLZ
- FDA submissions
- K170434
- 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
Product description
Agfa HealthCare Enterprise Imaging XERO Viewer
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Enterprise Imaging XERO Viewer 8Agfa HealthCare NV · System, Image Processing, Radiological2 recalls2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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