Recall Z-0755-2017— GE Healthcare, LLC

Name: FDA recall Z-0755-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-03

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-11-03, terminated 2018-09-17. It names 2 FDA 510(k) clearances: K131945, K112722. Product: GE Healthcare, Avance, Avance CS2, Amingo.. Reason: GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Terminated: 2018-09-17
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K131945 — GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda·cleared 2013-08-08
K112722 — GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc.·cleared 2011-12-16

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

GE Healthcare, Avance, Avance CS2, Amingo.

Reason for recall

GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.

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