ProductGuru Recalls

Official recall record

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replac

US FDA — Medical Devices · 2026-07-30 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2026-07-30
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
801042711
Brand on record
Datex-Ohmeda, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-29.

More recalls: US FDA — Medical Devices · United States · all filters

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