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.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AGFA Healthcare Corp. or your healthcare provider for instructions. Notification method: N/A
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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 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).
No specific incidents or injuries have been reported in connection with this recall. However, the potential for exceeding safe radiation levels poses a significant health risk.
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.
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.
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