FDA-Device2025-12-31Class IIPROCESSING DEFECT
AGFA DR 800 X-ray system recalled for potential radiation overdose in fluoroscopy
Nationwide distributionMedical devices
What this means
AGFA's DR 800 digital X-ray system can deliver higher radiation doses than the FDA allows during certain fluoroscopy procedures. This happens when the frame rate is increased on the NX workstation without proper safety features enabled. About 35 systems are affected nationwide.
- Contact AGFA Healthcare if you operate this equipment
- Do not increase frame rates without confirming safety systems are active
- Review AGFA's guidance on proper workstation configuration
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution.
Affected count
35
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2026Want us to check the next one for you?
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