Class 2 Device Recall ARTIS

• Date Initiated by Firm: December 16, 2022
• Date Posted: January 13, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0956-2023
• Recall Event ID: 91361
• 510(K)Number: K163286 K190768
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
• Code Information: 1) ARTIS pheno; Material #10849000; UDI/DI: 4056869046877 2) ARTIS icono biplane; Material #11327600; UDI/DI: 4056869063317 3) ARTIS icono floor; Material #11327700; UDI/DI: 4056869149325
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: Mechanical connection between the tabletop and table base may be lost.
• FDA Determined Cause: Device Design
• Action: A customer letter dated 12/16/2022 was issued to affected consignees. Consignees are advised the following: -Before treatment is started, check if both transversal guide rails and the roller bearing at the end of each rail are in the correct position. -For the affected OR tables, an inspection including installation of a safety measure will be carried out. Siemens is currently developing this mitigation. Once correction is available, the service department will contact the consignees to arrange a date to perform the corrective action. Consignees are requested to acknowledge the recall letter and return the acknowledgement form to Siemens promptly.
• Quantity in Commerce: 550 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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