Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 7/31/2013
Class ll:
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 6/26/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
29
DISTRIBUTION
Nationwide Distribution and Puerto Rico
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