Recall Z-1198-2018— GE Healthcare, LLC

Name: FDA recall Z-1198-2018
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: K012924. Product: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.. 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

K012924 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZERDatex-Ohmeda, Inc.·cleared 2002-01-30

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 TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

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.