Recall Z-1945-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1945-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-05-13, terminated 2014-11-06. It names one FDA 510(k) clearance: K090745. Product: Siemens AXIOM Artis zeego x-ray, angiographic system. Reason: Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K090745 — ARTIS ZEE / ZEEGOS WITH SW VC14Siemens Medical Solutions USA, Inc.·cleared 2009-06-18

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

Siemens AXIOM Artis zeego x-ray, angiographic system

Reason for recall

Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.

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