WhichRecall
Class IIReported 2025-12-31

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

Recalled by AGFA Healthcare Corp.

Reason for Recall

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams

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This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

Recall Number
Z-0923-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-18
Reported
2025-12-31
Distribution
U.S. Nationwide distribution.
Code Info
N/A
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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