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fda_recall · device_recall · high

Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t…

Event date
2026-09-23 00:00:00Z
Observed
2026-09-29 04:20:31Z
Source ID
Z-3192-2026
Payload hash
cb0b04dcbdba0cb59125b54c…

Summary

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 alarm… Status: Ongoing.

Entities

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Frequently asked questions

Has Datex-Ohmeda Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 7 total FDA actions tied to Datex-Ohmeda Inc: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-23; Argus observed and indexed it on 2026-09-29.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-3192-2026
MLA
"Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-datex-ohmeda-inc-z-3192-2026.
Chicago
Argus HQ Research. "Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t…." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-3192-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_datex_ohmeda_inc_z_3192_2026_2026,
  title = {Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-3192-2026},
  note = {Accessed: September 29, 2026}
}

Informational only. Not legal, financial, or medical advice.

Datex-Ohmeda, Inc. — Class II recall: Et Control, Software option for anesthesia gas machine to achieve and maintain t… · Argus HQ