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 Hamilton Medical AG Hamilton-C6 [Model Number: 160021 UDI-DI Code: 07630002808590 All Serial Numbers U.S.] [HKMD No.: 200332].
According to the FDA, the manufacturer has identified an issue due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90916
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Nov 2022