AGFA recalls DR 800 X-Ray systems that may exceed safe radiation levels if framerate is increased without ABS enabled. Affected units could pose radiation risks during pulsed fluoro exams.
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.
AGFA is recalling its DR 800 digital radiography systems because improper settings on the NX workstation could cause radiation levels to exceed safe limits during certain exams. This could potentially expose patients or staff to unnecessary radiation exposure.
The system may exceed the maximum safe radiation rate (88mGy/min) when the framerate is increased on the NX workstation without ABS enabled. This happens during pulsed fluoroscopy exams and could lead to unnecessary radiation exposure for patients or staff.
Healthcare facilities using AGFA DR 800 systems with NX workstations are most at risk. Patients and staff during pulsed fluoroscopy exams could be exposed to higher radiation levels if the system is misconfigured.
Check if your system has the model name 'DR 800' with MUSICA Dynamic. The product was sold by AGFA Healthcare Corp. as a digital radiography X-ray system.
Ensure ABS is enabled when increasing the framerate on the NX workstation to prevent exceeding radiation limits.
The recall involves systems that could pose radiation risks during exams if misconfigured, but patients are not directly affected by the recall itself.
Check if your system is labeled as 'AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic'.
Ensure ABS is enabled when increasing the framerate on the NX workstation to prevent exceeding radiation limits.
We’ve drafted a message you can send AGFA to request your refund or repair — edit it as you like.
Subject: Recall Z-0923-2026 — AGFA AGFA Hello, I own a AGFA that is covered by recall Z-0923-2026 from AGFA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
