Class 2 Device Recall Axiom Artis Fluoroscopic xray system

• Date Initiated by Firm: February 27, 2017
• Create Date: March 14, 2017
• Recall Status: Terminated on January 14, 2019
• Recall Number: Z-1468-2017
• Recall Event ID: 76615
• 510(K)Number: K052202
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Axiom Artis fluoroscopic x-ray system
• Code Information: Device Model: 4787813 Serial Numbers: 15260 20888 1104 20249 15197 10252 20019 20613 15508 10234 20425 21143 22191 20124 20369 20681 22147 21346 1260 10127 10107 10100 15238 20128 21959 21966 21217 1204 21419 20721 21235 22085 1129 20627 20637 1294 1295 20240 21439 20715 1444 20983 22439 20171 1085 21885 1119 17109 15692 1065 17227 17223 21622 10008 10094 20432 21722 1801 22421 10275 10462 20134 1673 15126 15152 20521 21887 21448 20131 22038 21710 20723 1356 1347 10006 17174 10115 22103 22154 17050 21006 20381 15028 15518 22344 21095 20693 20801 20802 20394 1279 10059 10084 15268 21857 20349 21000 1196 15291 20000 22113 15432 20923 20829 17182 17110 21913 21954 22150 17073 17160 20200 21823 20567 17099 21291 20420 20976 20399 1262 150099 20183 21564 20281 10451 15393 20684 20423 20083 20503 21025 20130 22098 15330 15079 20349 21810 21811 21850 21865 20125 21216 17211 20986 20445 20631 21972 21975 22140 10422 21889 20404 20239 21060 1051 1105 20388 1369 10095 17451 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• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-448-6461
• Manufacturer Reason for Recall: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
• FDA Determined Cause: Process control
• Action: A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.
• Quantity in Commerce: 2,158 units distributed in US and 6,139 worldwide
• Distribution: Distributed Nationwide
• 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 = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.