# FDA recall Z-3192-2026

> **Datex-Ohmeda, Inc.** · Class II · device recall initiated 2026-07-30.

## Product

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665

## 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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-3192-2026
- **Recalling firm:** Datex-Ohmeda, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-30
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3192-2026

## Citation

> MORVS. FDA recall Z-3192-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-3192-2026. Source: US FDA. Licensed CC0.

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