Recall Z-0706-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0706-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-06

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-06-06, terminated 2019-05-16. It names one FDA 510(k) clearance: K123529. Product: Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355. Reason: Potential for liquid entry.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Terminated: 2019-05-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2013-02-26

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 Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355

Reason for recall

Potential for liquid entry

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