FDA Medical Device Recalls (openFDA)
Agfa Healthcare NV: Agfa HealthCare Enterprise Imaging XERO Viewer
- Recall number
- Z-1004-2023
- Recalling firm
- Agfa Healthcare NV
- Product
- Agfa HealthCare Enterprise Imaging XERO Viewer
- Status
- Open, Classified
- Initiated
- 2022-12-05
- Posted
- 2023-01-20
- Terminated
- not on file
- 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 affected customers to schedule and apply appropriate software correction.
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K170434"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3009471886
- Firm city
- Mortsel
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28