Reported Dec 31, 2025 · Ongoing
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- Brand nameAGFA Digital Radiography X- Ray system
- DR 800 with MUSICA Dynamic Common NameDR 800
- Lot codes and dates
- N/A
- Amount recalled
- 35
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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