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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS ZEE AND ZEEGO

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  Class 2 Device Recall ARTIS ZEE AND ZEEGO see related information
Date Initiated by Firm July 13, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 on November 08, 2017
Recall Number Z-2395-2016
Recall Event ID 74716
510(K)Number K123529  
Product Classification System, x-ray, angiographic - Product Code IZI
Product ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22
AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are 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 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392  
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		 The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens has implemented a Customer Safety advisory Notice to all affected customer via Update Instruction AX007/15/S. Additional, a corrective action will be implemented via Update Instructions AX006/15/S and AX003/16/S.
Quantity in Commerce 11,111, worldwide and 3,187 in the USA
Distribution Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam
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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