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U.S. Department of Health and Human Services

Class 2 Device Recall Artis One

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  Class 2 Device Recall Artis One see related information
Date Initiated by Firm March 11, 2016
Create Date March 31, 2016
Recall Status1 Terminated 3 on November 17, 2017
Recall Number Z-1282-2016
Recall Event ID 73606
510(K)Number K133580  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis One, Interventional, Fluoroscopic, x-ray system
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
Code Information Serial # 82010, material # 10848600
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
FDA Determined
Cause 2		 Software in the Use Environment
Action Siemens mailed an Important Customer Safety Notice to customers to inform them of the issue and the corrective actions they plan to take to address the problem. The letter stated that Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers were instructed to call Siemens service organization for an appointment at 1-800-888-7436.
Quantity in Commerce 1 angiography system
Distribution Nationwide Distribution to Michigan only
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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