Recall Z-0075-2025— Datex-Ohmeda, Inc.

Name: FDA recall Z-0075-2025
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Class I · Ongoing

Class I FDA medical device recall by Datex-Ohmeda, Inc., initiated 2024-07-12. It names one FDA 510(k) clearance: K172045. Product: Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.. Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port..

Recalling firm: Datex-Ohmeda, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-07-12
Firm location: Madison, 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

Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Reason for recall

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

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