Recall – Software error leads to Angiography system C-arm leaving intended travel path

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 7/14/2021
Class II


ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Recall Number: Z-2029-2021


Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9″) result in canceling clinical treatment or to continue treatment on an alternative system


Siemens Medical Solutions USA, Inc. on 5/27/2021. Voluntary:  Firm Initiated recall is ongoing.


116 units


U.S. Nationwide

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