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 Philips Healthcare (Suzhou) Co., Ltd Incisive CT [Model or catalog number: 728143; All lots] [HKMD No.: 180534].
According to Health Canada, the manufacturer has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the incisive CT system. This component may become detached and make contact with other components located within the incisive CT during rotation. Other components could be damaged due to the contact with the detached component. If this issue occurs, a loud noise will be emitted and the system will shut down.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/philips-incisive-ct
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 May 2023