Agfa Healthcare NV: Agfa HealthCare Enterprise Imaging XERO Viewer

Hazard

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

Details from the source

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 Quantity: 110 units Lot/code info: 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

UPC codes

05400874000710

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.