Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 12/10/2014
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Recall Number Z-0486-2015
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the “Block Radiation” key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This would result in no X-ray release and a delay in procedure.
Siemens Medical Solutions USA, Inc., Malvern, PA on 9/11/2013 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally