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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee/ zeego, Artis Q/ Q.zen

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  Class 2 Device Recall Artis zee/ zeego, Artis Q/ Q.zen see related information
Date Initiated by Firm July 07, 2016
Create Date August 05, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall Number Z-2344-2016
Recall Event ID 74655
510(K)Number K073290  K123529  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled
Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255
Artis zee / zeego and Q/ Q.zen 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,109187,124102,121167,125021,121163,117125,148001,158234,148010,158229,121171, 109183,109181,131101,158226,109194,117124,158244,109179,158238,109188,121179,137714,121168,158246,161022,121175,121173,154859,109186,158230,123046,158227,109189,123052,105029,105030
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		 Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Important Customer Safety Notice dated July 7, 2016, by certified mail to customers to inform them of the corrective action they plan to take to prevent potential loss of the image display for live images in the examination room after system startup. Siemens service organization will contact each customer to arrange a date to resolve the issue with a software update of the monitor firmware via AX012/16/S. For questions regarding this recall call 610-448-6461.
Quantity in Commerce 51 units
Distribution Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV
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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