Recall Z-1285-2022— GE Healthcare, LLC

Name: FDA recall Z-1285-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-25

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-04-25. It names one FDA 510(k) clearance: K172045. Product: Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019. Reason: Backup batteries can fail earlier than their estimated life..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-25
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

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

Reason for recall

Backup batteries can fail earlier than their estimated life.

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