Agfa recalls DX-D 100 mobile X-ray systems with potential cable interference causing safety system failure and patient injury. Models 5411/050, A5411/0300, A5411/0400 affected.
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
Agfa is recalling its DX-D 100 mobile X-ray systems because a steel cable inside the mobile column could interfere with the safety system that prevents patient injury if the cable is cut. This risk exists in specific models with serial numbers listed in the recall.
A steel cable inside the mobile column that supports the telescopic arm has a potential risk of interference. If this cable is cut, the safety system that blocks the arm may not work properly, which could lead to patient injury.
Healthcare facilities using the recalled Agfa DX-D 100 mobile X-ray systems are most at risk, particularly those with the listed serial numbers. Patients receiving X-rays on these systems could be injured if the safety mechanism fails.
Check if your Agfa DX-D 100 system has serial numbers listed in the recall (US, Canada, or foreign serial numbers provided in the notice). The affected models are 5411/050, A5411/0300, and A5411/0400.
Verify if your system has a serial number listed in the provided US, Canada, or foreign serial numbers.
The affected models are 5411/050, A5411/0300, and A5411/0400.
Check if your system's serial number is listed in the US, Canada, or foreign serial numbers provided in the recall notice.
The recall requires checking if your serial number is listed; no specific remedy is stated in the official notice.
We’ve drafted a message you can send Agfa to request your refund or repair — edit it as you like.
Subject: Recall Z-1462-2024 — Agfa Agfa Hello, I own a Agfa that is covered by recall Z-1462-2024 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.