FDA recall Z-1004-2023

Product

Agfa HealthCare Enterprise Imaging XERO Viewer

Reason for recall

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

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

Key facts

Status

Ongoing

Initiation date

2022-12-05

Report date

2023-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mortsel, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2023