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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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