Agfa recalls DR 800 X-ray systems with TomoSynthesis that may not stop image acquisition after expected exposures, posing a risk of overexposure. Affected units have specific serial numbers.
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Agfa is recalling its DR 800 X-ray systems with TomoSynthesis technology because the image acquisition sequence might not stop automatically after the expected number of exposures. This could lead to overexposure of the patient. The recall affects specific units with serial numbers 00949 and 1161.
The Tomosynthesis image acquisition sequence may not stop automatically after the expected number of exposures. This could result in overexposure of the patient during an X-ray procedure. The system is designed for general X-ray applications, not mammography.
Users of the Agfa DR 800 X-ray system with TomoSynthesis technology are affected, particularly those with the specific serial numbers 00949 and 1161. Medical facilities using this equipment are most at risk.
Check if your Agfa DR 800 X-ray system has TomoSynthesis technology. Affected units have serial numbers 00949 and 1161. The product is not intended for mammography use.
Verify your unit's serial number to see if it is 00949 or 1161.
No, the DR 800 is not intended for mammography applications.
Check if your unit's serial number is 00949 or 1161. If so, contact Agfa for further instructions.
The Tomosynthesis image acquisition sequence may not stop automatically after the expected number of exposures, potentially causing overexposure.
We’ve drafted a message you can send Agfa to request your refund or repair — edit it as you like.
Subject: Recall Z-1502-2020 — Agfa Agfa Hello, I own a Agfa that is covered by recall Z-1502-2020 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.
