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 20) drew users’ attention to the safety issue related to the Maquet Surgical Lights of Getinge.
According to the Hospital Authority (HA), there was an accidental fall of a surgical light in a hospital's operation room of the United Christian Hospital on 18 February 2023. According to the preliminary findings by the local supplier, the incident was related to the Maquet VOLISTA Surgical Lights (Model: VOLISTA 600 STANDOP) of Getinge and the problem may be related to the conditions of the suspension fixing screws used in the surgical lights. Further investigation by the HA and the manufacturer is on-going. Please refer to the press release issued by Hospital Authority on 19 Feb 2023 for more details about the incident - https://www.info.gov.hk/gia/general/202302/19/P2023021900427.htm?fontSize=1
According to the local supplier, the affected product is distributed in Hong Kong, including the public, private hospitals and day procedural centres.
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 that the device should be assembled, mounted, used and maintained in accordance with the manufacturer’s advice and the device’s instruction for use (IFU).
Posted on 20 Feb 2023