Class 2 Device Recall Swissray ddRCombi Trauma

• Date Initiated by Firm: November 14, 2018
• Date Posted: January 08, 2019
• Recall Status: Terminated on September 01, 2021
• Recall Number: Z-0697-2019
• Recall Event ID: 81749
• 510(K)Number: K050718
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• 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.
• Code Information: Serial Numbers: S403088, S403089, S403165
• Recalling Firm/ Manufacturer: Swissray Medical AG; Turbistrasse 25-27; Hochdorf Switzerland
• For Additional Information Contact: Deniz Kortan; 908-372-6408
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: A component of the device was recalled by a supplier (Siemens AG/Siemens Healthcare GmbH), as a result, Swissray Medical AG, sent an "Important Warning / Important Safety Notice" letters dated 11/14/18 to its customers. The letter described the product, problem and actions to be taken. The firm stated safety related retrofits are available for installation to eliminate risk to patients and users.The retrofit aims to completely correct the problem. The customers were instructed to do the following: To mitigate risk to patients and users until the retrofit modification is implemented, users are strongly advised not to move the column up/down directly above the patient, but to instead first perform vertical movement next to the patient, and then horizontally position over the patient at a fixed height. Please ensure that all your users who own the affected products and others who are aware or them receive the safety-related information provided with this safety notice, and comply with the recommendations contained therein. If you have any questions, contact US Agent of Swissray Medical AG, QA/RA Coordinator at 908-372-6408 or email: Deniz.Kortan@swissray.com.
• Quantity in Commerce: 3
• Distribution: Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQB