Swissray Medical AG: Medical Device Recall in 2019 - (Recall #: Z-0697-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 14, 2018

Date Posted: January 16, 2019

Recall Number: Z-0697-2019

Event ID: 81749

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3

Code Information:

Serial Numbers: S403088, S403089, S403165

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated