Recall Z-0083-2025— Datex-Ohmeda, Inc.
Class I · Ongoing
Class I FDA medical device recall by Datex-Ohmeda, Inc., initiated 2024-07-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.. Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port..
- Recalling firm
- Datex-Ohmeda, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-07-12
- Firm location
- Madison, WI, United States
Product description
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason for recall
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Data sourced from openFDA. This site is unofficial and independent of the FDA.