Recall Z-3189-2026— Datex-Ohmeda, Inc.

Name: FDA recall Z-3189-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Class II · Ongoing

Class II FDA medical device recall by Datex-Ohmeda, Inc., initiated 2026-07-30. It names one FDA 510(k) clearance: K172045. Product: Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000. Reason: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect..

Recalling firm: Datex-Ohmeda, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-30
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

Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000

Reason for recall

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

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