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 Canon Medical Systems Corporation Infinix and Alphenix Systen C-Arm Suspension and Table [Products: Alphenix Infx-8000c, Alphenix Infx-8000v, C-Arm Support, Infinix Cc-I-System, Infinix Cf-1/Bp-System, Infinix Cf-I/Sp-System, Infinix Vc-I-System, Infinix Vf-I/Bp-System, Infinix Vf-I/Sp-System] [HKMD number: 230222].
According to Health Canada, it has been discovered that the affixing screws of the C-arm motor drive and table, that are part of the x-ray interventional system, may become loose. As a result, abnormal noises may be generated from the C-arm suspension and/or the table. Also, sensor errors may be displayed. However, please note that the affixing parts will not fall nor fail.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/infinix-and-alphenix-systen-c-arm-suspension-and-table
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jun 2024