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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Q/ Q zen systems

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  Class 2 Device Recall Artis Q/ Q zen systems see related information
Date Initiated by Firm March 19, 2015
Date Posted April 14, 2015
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-1445-2015
Recall Event ID 70830
510(K)Number K123529  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis Q/ Q zen systems; Artis Q/ Q zen systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Code Information Model Number of device:10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 with serial numbers: 109033 123026 121061 121089 121094 109080 109074 121006 121013 121040 109119 111005 109016 121062 109118 111002 121082 121011 121039 123008 109066 109067 109068 121053 121054 117001 117023 123003 123011 103030 109084 121014 121051 109011 109096 121004 117021 121018 121036 123013 123014 117029 117006 121012 121049 103013 109102 121078 109015 109009 121019 109057 121010 117034 109108 103008 109103 121081 109038 109040 109034 117020 105016 109029 121096 111003 123025 121015 109064 117018 117030 109058 121016 109050 109076 117026 123022 109007 103001 111000 109071 109072 109075 121020 109091 109090 109041 109039 109060 121047 123023 123024 117024 121088 109088 121027 103028 109092 109032 121009 121056 121057 109021 121034 121008 109048 109020 109036 109043 123027 109101 109104 109105 109107 121058 121085 109047 117040 109031 109027 109028 105017 109010 109093 121071 109069 117014 123010 117009 121023 123015 123016 121079 121041 109044 121037 121046 105007 121072 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Mail Code: 65-1A
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.
FDA Determined
Cause 2		 Employee error
Action A customer notification, dated March 19, 2015, was distributed to all affected customer via AX018/15/S. Additionally, Siemens has initiated an inspection of Artis Q/ Q zen systems via Update Instruction AX017/15/S.
Quantity in Commerce 139
Distribution Nationwide
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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