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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Event Detail

Event ID 65793
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 2013-04-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Distribution including the states of PA, NJ, DC, VA, MD and DE.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509. Class II The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. 178 Z-2108-2013
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