Class 2 Device Recall ARTIS Pheno

• Date Initiated by Firm: December 20, 2019
• Create Date: January 13, 2020
• Recall Status: Terminated on May 01, 2020
• Recall Number: Z-0807-2020
• Recall Event ID: 84648
• 510(K)Number: K163286
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
• Code Information: Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: 610-219-4834
• Manufacturer Reason for Recall: The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
• FDA Determined Cause: Device Design
• Action: Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
• Quantity in Commerce: 6
• Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
• 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