Recall Z-1389-2022— GE Healthcare, LLC

Name: FDA recall Z-1389-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-01

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2022-06-01, terminated 2024-10-21. It names one FDA 510(k) clearance: K172045. Product: GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.. Reason: There is a potential reversal of the O2 and air cylinder pressure transducer connections..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2022-06-01
Terminated: 2024-10-21
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 Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

Reason for recall

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

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