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 AGFA Digital Radiography X-Ray system DR 800 is used in medical facilities for imaging patients. It allows for advanced imaging techniques that improve diagnostic capabilities.
The system may exceed the safe radiation levels during pulsed fluoroscopy exams if certain settings are not correctly configured, potentially exposing patients to harmful radiation.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease use of the device, which may disrupt imaging services until the issue is resolved.
Model numbers and other identifiers can typically be found on the back or sides of the device.
Expect a timeline of 4-6 weeks for refund processing once you contact AGFA Healthcare.
Keep records of your purchase, any correspondence with AGFA Healthcare, and documentation of the recall.
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.
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