Recall Z-0707-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0707-2018
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: K073290. Product: Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354. 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

K073290 — ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc.·cleared 2008-02-11

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 Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354

Reason for recall

Potential for liquid entry

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