Recall Z-1427-2022— GE Healthcare, LLC

Name: FDA recall Z-1427-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-27

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-05-27. It names one FDA 510(k) clearance: K172045. Product: GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.. Reason: The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-05-27
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 Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

Reason for recall

The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

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