Recall Z-0313-2021— GE Healthcare, LLC

Name: FDA recall Z-0313-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-09-17. It names one FDA 510(k) clearance: K172045. Product: GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.. Reason: Flow sensors could have damaged tubes in the form of small punctures or cuts..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-09-17
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc.·cleared 2017-11-03

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 Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.

Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

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