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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description AXIOM 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.
Recall Number Z-1272-2014
Classification Class II
Code Info 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
Product Distributed Qty 37
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.

Event Detail

Event Id 67556
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
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