Recall Z-1199-2018— GE Healthcare, LLC

Name: FDA recall Z-1199-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-04

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-10-04, terminated 2020-04-10. It names one FDA 510(k) clearance: K170872. Product: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.. Reason: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Terminated: 2020-04-10
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K170872 — Aisys CS2Datex-Ohmeda, Inc.·cleared 2017-08-15

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

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

Reason for recall

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

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