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 (March 2) drew users’ attention to the safety issue related to Gate motor box of Track System for Maxi Sky ceiling lifters by ArjoHuntleigh AB.
It came to DH’s attention that the Hospital Authority (HA) has issued a press release on 1 Mar 2023 23:45 about the external cover of a ceiling hoist track for patient lifting dropped in a Ward of HA’s hospital on 1 March 2023. According to HA, the involved part was the cover of the Gate motor box of the Maxi Sky ceiling lifters by ArjoHuntleigh AB. Please refer to the link below for more details about the press release issued by HA https://www.info.gov.hk/gia/general/202303/01/P2023030100864.htm.
MDD has contacted the local supplier and confirmed that this incident involved the cover of the gate box on the track system for the device. According to the updated information from the local supplier, the affected Gate motor box is distributed in Hong Kong, including the public hospitals special schools and residential care homes.
If you are in possession of the affected products, please contact the supplier for necessary actions.
Users of medical devices, 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 2 Mar 2023
(Updated on 3 March 2023)