Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Datex-Ohmeda, Inc. Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. [HKMD No.: 130469, 120542].
The medical device safety alert is initiated due to there is a potential reversal of the O2 and air cylinder pressure transducer connections.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90424
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Aug 2022