Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 7/14/2021
Class II
PRODUCT
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Recall Number: Z-2029-2021
REASON
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
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 5/27/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
U.S. Nationwide