Home / Recalls / Agfa Healthcare NV / Z-1004-2023

Z-1004-2023 Class II Ongoing

Recalled by Agfa Healthcare NV — Mortsel, N/A

Recall Details

Product Type
Devices
Report Date
February 1, 2023
Initiation Date
December 5, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110 units

Product Description

Agfa HealthCare Enterprise Imaging XERO Viewer

Reason for Recall

There is a software defect that can cause issues with images.

Distribution Pattern

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

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

Other recalls by Agfa Healthcare NV

  • Z-0923-2026 Class II — Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic C (November 18, 2025)
  • Z-0055-2025 Class II — Enterprise Imaging XERO Viewer- software application used for reference and diag (September 6, 2024)
  • Z-0101-2019 Class II — Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Card (August 3, 2018)
  • Z-2652-2017 Class II — IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and g (December 22, 2016)
  • Z-2735-2017 Class II — Agfa Healthcare NX 3.0.8950 Imaging Processing Software (December 21, 2016)
  • Z-1738-2017 Class II — DX-D600 - DXD Imaging Package (May 2, 2016)
  • Z-1698-2017 Class II — AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in p (January 20, 2016)
  • Z-0283-2016 Class II — IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX (September 1, 2015)
  • Z-2061-2015 Class II — IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archivin (June 26, 2015)
  • Z-1745-2015 Class II — AGFA DX-D 100 is a mobile digital radiography x-ray system (May 29, 2015)