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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Device Recall Siemenssee related information
Date Initiated by FirmFebruary 07, 2014
Date PostedMarch 22, 2014
Recall Status1 Terminated 3 on December 30, 2014
Recall NumberZ-1272-2014
Recall Event ID 67556
510(K)NumberK073290 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductAXIOM Artis Systems Product usage: 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.
Code Information Model nos. 7412807, 7727717, 7728392 with serial numbers: 35020, 34999,35098 35113 35042 35061 35064 35073 35014 35069 35053 35055 35056 35054 35008 35057 35044 35018 35097 35108 35046 35048 35050 35045 35004 35019 46004 46005 40000 40009 40011 40006 40007 40010 44016 44005 44011 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
FDA Determined
Cause 2		Device Design
ActionSiemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.
Quantity in Commerce37
DistributionUSA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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