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

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

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