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AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Recalled December 31, 2025 · FDA recall Z-0923-2026 · AGFA Healthcare
Hazard
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. · FDA Class II
Units
35
Sold at
U.S. Nationwide distribution.
Description
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.
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Manufacturer(s)
AGFA Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →