Class II
Medical Device Recall: Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare Corp. · November 18, 2025
Reason for Recall
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.
Distribution
U.S. Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
35
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0923-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.