Datex-Ohmeda, Inc. — Class II: Et Control, Software option for anesthesia gas machine to achieve and maintain targeted en
Datex-Ohmeda, Inc. has initiated a Class II recall for the Et Control software option due to an issue where anesthesia machines may automatically transition to Alternate O2 control. This transition delivers 100% oxygen, triggers alarms, and interrupts the delivery of anesthetic agents, necessitating clinician intervention to prevent decreased anesthetic effect.
This recall affects Datex-Ohmeda, Inc., clinical users of anesthesia gas machines equipped with the Et Control software option (FRU part numbers 1011-8000-000-S and 5700665), and healthcare facilities managing these devices.
The automatic transition to Alternate O2 control represents a deviation from intended device performance that could lead to unintended patient awareness if clinicians do not respond promptly to alarms. From a regulatory perspective, this highlights the critical nature of software-controlled gas mixing and the potential for secondary risks (e.g., inadequate anesthesia) when fail-safe mechanisms—like 100% O2 delivery—are triggered.
Clinical sites should identify anesthesia machines utilizing the affected Et Control software FRUs and ensure staff are trained to recognize Alternate O2 control alarms. QA teams should verify that risk files adequately address the interruption of anesthetic delivery and the necessity of clinician intervention during gas mixer transitions.
Class II. 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.. 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. Firm: Datex-Ohmeda, Inc. (Madison WI United States). Status: Ongoing.
Open in openFDA / FDA.gov