Safety Alerts

Safety Alerts

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.

Medical Device Safety Alert: Datex-Ohmeda, Inc. Aisys CS2, Avance CS2 and Avance CS2 Pro Anesthesia System.

03 Aug 2022

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

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 3 Aug 2022