Agfa recalls DR 800 X-Ray systems with MUSICA Dynamic (Type 6010/200) due to potential incorrect dose calculations during fluoroscopy exams. Affected units have specific serial numbers; users should contact Agfa for details.
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
Agfa is recalling its DR 800 X-Ray systems with MUSICA Dynamic software (Type 6010/200) because under certain conditions, like fluoroscopy exams with the ABS feature off and manual parameter changes, the system might calculate the wrong dose per minute. This could lead to incorrect radiation exposure during medical imaging.
The system can miscalculate the dose per minute during fluoroscopy exams when the ABS feature is turned off and parameters are manually changed. This risk occurs only under specific conditions and does not affect all uses of the device.
Healthcare providers using the DR 800 X-Ray system for fluoroscopy exams are most at risk. Patients undergoing these exams may receive unintended radiation exposure if the system calculates the wrong dose.
Check for the serial numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404. The product is used for fluoroscopy and rapid sequence imaging in medical settings.
Identify if your DR 800 system has one of the listed serial numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, or 1404.
The system can miscalculate the dose per minute during fluoroscopy exams when the ABS feature is off and parameters are manually changed, potentially leading to incorrect radiation exposure.
The recall record does not specify a remedy; contact Agfa directly for further instructions.
Under normal use conditions, the product is safe. The risk only occurs under specific conditions like fluoroscopy exams with the ABS feature off and manual parameter changes.
We’ve drafted a message you can send Agfa to request your refund or repair — edit it as you like.
Subject: Recall Z-2202-2020 — Agfa Agfa Hello, I own a Agfa that is covered by recall Z-2202-2020 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.
