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 Hamilton Medical AG Hamilton-C6 Intensive Care Ventilator [Model or catalog number: 160021; Lot or serial number: SW v1.1.5, SW v1.1.6, SW v1.1.4] [HKMD No.: 200332].
According to Health Canada, this field safety notice (FSN) provides information about an identified software anomaly that is associated with the use of ventilator software on the ventilator Hamilton-C6. In addition to the steps to follow as identified in the FSN, the newest available software version 1.2.3 contains the required fix and shall be installed without undue delay to minimize overall risk during use of Hamilton-C6.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/hamilton-c6-intensive-care-ventilator-2
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 May 2024