Recall Z-0079-2025— 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: Amingo. OUS only.. 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
Amingo. OUS only.
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.