Agfa Healthcare NV: Medical Device Recall in 2023 - (Recall #: Z-1004-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Agfa HealthCare Enterprise Imaging XERO Viewer

Product Classification:

Class II

Date Initiated: December 5, 2022

Date Posted: February 1, 2023

Recall Number: Z-1004-2023

Event ID: 91357

Reason for Recall:

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

Status: Ongoing

Product Quantity: 110 units

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

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

Voluntary or Mandated:

Voluntary: Firm initiated