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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Q and Q.Zen

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  Class 2 Device Recall Artis Q and Q.Zen see related information
Date Initiated by Firm June 06, 2017
Create Date February 23, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall Number Z-0706-2018
Recall Event ID 79097
510(K)Number K123529  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355

Code Information 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392
Recalling Firm/
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith.adams@siemens.com
Manufacturer Reason
for Recall
Potential for liquid entry
FDA Determined
Cause 2
Device Design
Action On June 6, 2017, Siemens Healthineers distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via USPS Certified Mail. Siemens conducted a corrective field action in June 2015 to protect the Artis table against liquid entry at critical locations. However, even with this corrective action, if there are larger amounts of liquid on the table surface, they can still enter the table. Siemens Medical Solutions USA, Inc. will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment by calling 610-448-6461.
Distribution U.S. 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.