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.
Health Canada has posted a medical device safety alert concerning Datex-Ohmeda, Inc. Aisys, Avance, and Aespire Anesthesia Machines [Model or Catalog Number: 1009-9012-000, 1009-9000-000, 1011-9000-000, 1011-9050-000, 1009-9050-000, 1009-9002-000] [HKMD number: 120542, 130469].
According to Health Canada, the manufacturer has become aware of a potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/aisys-avance-and-aespire-anesthesia-machines
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Aug 2024