Recall Z-2029-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2029-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-27

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-05-27. It names 2 FDA 510(k) clearances: K201156, K163286. Product: ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000. 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: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-05-27
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K201156 — ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.·cleared 2020-06-29
K163286 — ARTIS phenoSiemens Medical Solution USA, Inc.·cleared 2017-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.