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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Pheno

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  Class 2 Device Recall ARTIS Pheno see related information
Date Initiated by Firm December 20, 2019
Create Date January 13, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTION USA, INC.
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