Agfa recalls specific DX-D 600 ceiling-mounted X-ray systems due to potential cable failure that could cause equipment to fall, harming patients or others. Affected units have serial numbers starting with A5430000015.
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.
Agfa is recalling certain DX-D 600 ceiling-mounted X-ray systems because steel support cables might break, risking the equipment falling and causing injury to patients or people nearby. This recall affects specific serial numbers listed in the notice.
The system uses two steel cables to support the X-ray equipment on its ceiling mount. If these cables break, the equipment could fall, potentially causing injury to patients or people nearby. The recall addresses a potential issue with cable deterioration or pulley wear that could lead to failure.
Healthcare facilities using the DX-D 600 system for X-ray imaging in hospitals, clinics, or medical practices are affected. Patients and staff are at risk if the equipment falls due to cable failure.
Check if your X-ray system has a serial number starting with A5430000015 through A5430000374. The DX-D 600 system is used for ceiling-mounted X-ray imaging in medical settings.
Verify if your system has a serial number starting with A5430000015 through A5430000374.
Reach out to Agfa for guidance on whether your system needs cable replacement or pulley inspection.
Agfa identified a potential risk that the steel support cables could break, which might cause the X-ray equipment to fall and harm patients or others.
Check if your system has a serial number starting with A5430000015 through A5430000374. If it does, contact Agfa for instructions on cable or pulley inspection.
Yes, if the two support cables break, the equipment could fall and cause injury to patients or people nearby.
We’ve drafted a message you can send Agfa to request your refund or repair — edit it as you like.
Subject: Recall Z-3245-2018 — Agfa Agfa Hello, I own a Agfa that is covered by recall Z-3245-2018 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.