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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Recall Number Z-1782-2013
Classification Class II
Code Info Model numbers: 10094137, 10094139, 10094141, 10280959
Product Distributed Qty 29
Reason For Recall Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aquisition, the subtraction is not correctly displayed on the live monitor in the control room. As subtracted images are not displayed correctly, this may lead the user to abort or redo the 3D protocol, potentially resulting in the application of an additional dose or contrast agent. 3D data are saved however, and available on the system.

Event Detail

Event Id 65651
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 2013-06-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution and Puerto Rico