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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 Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Recall Number Z-1202-2014
Classification Class II
Code Info model numbers 10848280, 10848281, 10848282, and 10848283.
Product Distributed Qty 19
Reason For Recall There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

Event Detail

Event Id 67016
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 2013-12-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
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