Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Department of Health (DH) today (February 24) drew users’ attention to the updated information related to the safety of the Maquet Surgical Lights of Getinge.
On 20 February 2023, a special safety alert was issued related to the incident of a ceiling-mounted Maquet Surgical Lights of Getinge in one of the public hospital. For more details please refer to https://www.mdd.gov.hk/en/safety-alerts-communications/safety-alerts-special-alerts/md-not-listed-under-mdacs/special-alerts/index-id-2234.html
Today, the manufacturer notified the Department of Health that at this early stage of investigation, the incident may be related to the problem of the screws fixing the device. The following devices using the same fixing means may be affected:
According to the local supplier, the affected products are distributed in Hong Kong, including the public and private hospitals. If you are in possession of the affected products, please contact the supplier for necessary actions.
Users of medical devices, including ceiling-mounted surgical lights, are reminded again that the device should be assembled, mounted, used and regularly maintained in accordance with the manufacturer’s advice and the device’s instruction for use (IFU).
Posted on 24 Feb 2023