Recall Z-2108-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2108-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-26

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-04-26, terminated 2014-11-06. It names one FDA 510(k) clearance: K021021. Product: Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.. Reason: The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-26
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K021021 — MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTISSiemens Medical Solutions USA, Inc.·cleared 2002-06-06

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

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

Reason for recall

The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

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