Swissray Medical Recalls ddRCombi Plus FP X-ray Systems Due to Lifting Column Defect

Plain-English summary

Swissray Medical AG is recalling three units of the ddRCombi Plus FP, a fully digital, multifunctional X-ray system used for orthopedics, trauma, and pulmonary imaging. The affected model numbers are 8.2000.0070.0 (US Version) and 8.2000.0060.0 (Europe Version). The specific serial numbers for the recalled units are S403088, S403089, and S403165.

The recall is due to a defect in a component supplied by a third party. In rare cases involving inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column may break without triggering the safety lock. This failure can overload the safety cable, which is not designed to permanently carry the load or move continuously under load. This condition can lead to material fatigue and cause the X-ray arm to drop unexpectedly during patient positioning.

The affected devices were distributed worldwide, including in the United States (Illinois and Massachusetts) and in the Czech Republic, Germany, Poland, and Peru. If the arm drops unexpectedly, patients and users may be seriously injured. Users should contact Swissray Medical AG for further instructions on how to address this defect.

The recalled product

Product

ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all

Manufacturer

Swissray Medical AG

Category

Medical Device — Imaging Equipment

Hazard

• falling-object
• structural-failure

Affected units

3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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