Class 2 Device Recall Cios Fusion Interventional fluoroscopic xray system

• Date Initiated by Firm: June 20, 2019
• Create Date: July 09, 2019
• Recall Status: Terminated on April 17, 2020
• Recall Number: Z-1954-2019
• Recall Event ID: 83255
• 510(K)Number: K153244
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Cios care fusion system
• Code Information: material # 10308192 Serial # 31375
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Anastasia Sokolova; 610-219-4834
• Manufacturer Reason for Recall: DAP chamber may be missing an insulating foil
• FDA Determined Cause: Nonconforming Material/Component
• Action: 1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
• Quantity in Commerce: 1
• Distribution: IL, NE
• 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