- Recalling firm
- Datex-Ohmeda, Inc.
- 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.
- Affected products (lot / model / serial)
- Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Units affected
- 7 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Madison, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3191-2026
- Recall initiated
- July 30, 2026
- FDA classification date
- September 16, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99649
- Last updated on HTM Vibe
- September 29, 2026