Swissray Medical recalls specific X-ray models due to rare risk of arm dropping during patient positioning, potentially causing serious injury. Affected units have serial numbers S403088, S403089, S403165.
A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured.
Swissray Medical is recalling certain X-ray systems (ddRCombi Plus FP models) because a component can break under high workload, causing the arm to drop unexpectedly and potentially injuring patients or users. This risk occurs in rare cases of inadequate maintenance or very high clinical use.
The device's first steel wire rope can break without activating the safety lock under rare conditions like poor maintenance or extremely high usage. This causes the lifting arm to drop suddenly, potentially injuring patients or users during medical procedures.
Healthcare facilities using the affected X-ray models are most at risk. Patients and staff during procedures using these systems could be injured if the arm drops unexpectedly.
Check for serial numbers S403088, S403089, or S403165 on the device. The affected models are the ddRCombi Plus FP with US version model 8.2000.0070.0 or Europe version model 8.2000.0060.0.
Look for serial numbers S403088, S403089, or S403165 on the device.
The device's first steel wire rope can break without triggering the safety lock under rare conditions like inadequate maintenance or very high clinical workload, potentially causing the lifting arm to drop unexpectedly and injuring patients or users.
The affected models are the ddRCombi Plus FP with US version model 8.2000.0070.0 or Europe version model 8.2000.0060.0, with serial numbers S403088, S403089, and S403165.
The recall record does not specify a remedy. Affected users should check the serial number and contact Swissray Medical for further instructions.
We’ve drafted a message you can send Swissray Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0697-2019 — Swissray Medical Swissray Medical Hello, I own a Swissray Medical that is covered by recall Z-0697-2019 from Swissray Medical. 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.
