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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee angiographic xray system

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  Class 2 Device Recall Artis zee angiographic xray system see related information
Date Initiated by Firm February 03, 2017
Create Date July 14, 2017
Recall Status1 Terminated 3 on October 24, 2017
Recall Number Z-2686-2017
Recall Event ID 77201
510(K)Number K073290  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Artis zee,x-ray system, angiographic
Artis zee 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. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Code Information Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035 
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		 Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
FDA Determined
Cause 2		 Component design/selection
Action CDRH approved the CAP subject to the following conditions: 1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. 2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
Quantity in Commerce 97 distributed worldwide, 12 distributed in United States
Distribution Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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