FDAHealthNovember 18, 2025
AGFA Healthcare Corp. — Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 18, 2025
U.S. Nationwide distribution.
What's affected?
- Product
- Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
- Lot code
- N/A
Additional details
N/A
What should I do?
Recommended action
Class II recall. FDA Mandated Quantity affected: 35.
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