Recall Z-0697-2019— Swissray Medical AG

Name: FDA recall Z-0697-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Class II · Terminated

Class II FDA medical device recall by Swissray Medical AG, initiated 2018-11-14, terminated 2021-09-01. It names one FDA 510(k) clearance: K050718. 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 applications in orthopedics and trauma as well as pulmonary imaging.. Reason: 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..

Recalling firm: Swissray Medical AG
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Terminated: 2021-09-01
Firm location: Hochdorf, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K050718 — DDRCOMBI TRAUMASwissray International, Inc.·cleared 2005-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.