Swissray Medical AG recalls ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a ful…

Recall date

November 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0697-2019

FDA classification

Class II

Brand / firm

Swissray Medical AG

Sold / distributed

Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 applications in orthopedics and trauma as well as pulmonary imaging.