Z-1004-2023Class II

Agfa HealthCare Enterprise Imaging XERO Viewer

Name: Z-1004-2023 Agfa HealthCare Enterprise Imaging XERO Viewer
Creator: Agfa Healthcare NV
Published: 2022-12-05
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2022-12-05 / Open, Classified / root cause: software

FDA source

Agfa Healthcare NV began a recall of Agfa HealthCare Enterprise Imaging XERO Viewer on 2022-12-05. FDA classified it as Class II and gives the reason as "There is a software defect that can cause issues with images". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1004-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-05
Posted: 2023-01-20
Recalling firm: AGFA Healthcare Corp.
Product: Agfa HealthCare Enterprise Imaging XERO Viewer
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a software defect that can cause issues with images.
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1004-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20

Product code LLZ

K170434Class IIEnterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. / cleared 2017-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)