AGFA Recalls Digital Radiography X-Ray System Over Radiation Risk
AGFA Healthcare recalled 35 Digital Radiography X-Ray systems on November 18, 2025, due to a risk of exceeding safe radiation levels. The recall affects systems distributed nationwide in the U.S. Users must stop using the device immediately and follow manufacturer instructions.
Product Details
The recalled product is the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic. It is classified as a Class II device and has a quantity of 35 units recalled. These systems were distributed nationwide in the U.S.
The Hazard
The system may exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min during pulsed fluoroscopy exams. This occurs if the framerate is increased on the NX workstation without enabling Automatic Brightness Stabilization (ABS).
What to Do
Immediately stop using the AGFA Digital Radiography X-Ray system DR 800. Contact AGFA Healthcare Corp. or your healthcare provider for further instructions and follow the recall procedures provided.
Contact Information
For more information, visit the AGFA Healthcare recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0923-2026. Patients can also call AGFA Healthcare Corp. for assistance.