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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Q/ Q.Zen biplane Artis Zee biplane

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  Class 2 Device Recall Artis Q/ Q.Zen biplane Artis Zee biplane see related information
Date Initiated by Firm August 24, 2017
Create Date February 03, 2018
Recall Status1 Terminated 3 on August 29, 2018
Recall Number Z-0508-2018
Recall Event ID 79039
510(K)Number K123529  K073290  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AArtis Q/ Q.Zen biplane
Artis zee biplane
Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Code Information 10094141 10848282 10848355 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
FDA Determined
Cause 2		 Employee error
Action Siemens sent an Urgent: Medical Device Correction letter dated August 24, 2017 to all affected customers. The letter identified the affected product, problem and actions to be taken. A local management or dispatch will schedule for an inspection to correct the issue. For questions please call 1-800-888-7436
Quantity in Commerce 265 units
Distribution US Nationwide Distribution
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.
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