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-C2/C3/C1/T1 ventilators [Model or catalog number:: 161001, 160001, 160002, 160005, 161006, 161009] [HKMD No.: 170303, 200322].
According to Health Canada, the manufacturer has become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device will switch to "ambient state" and therefore stop ventilation.
During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hence, it is mandatory to apply a periodic preventive restart of affected devices. Devices and software version affected:
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/hamilton-c2c3c1t1-ventilators
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Jun 2023