AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

Recall date

November 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0923-2026

FDA classification

Class II

Brand / firm

AGFA Healthcare Corp.

Sold / distributed

U.S. Nationwide distribution.

Why it was recalled

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800