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 Canda has posted a medical device safety alert concerning Mobius Imaging, LLC. Airo Mobile CT System [Model or catalogue number: MOBICT-32; Lot or serial number: All lots.] [HKMD number: 220345].
According to the Health Canada, as part of continuous improvement efforts the Airo software was reviewed as per Stryker procedure. During review Stryker has identified software bugs that may impact device performance and user experience. These software issues are present on previous software release versions (1.3.0-2.1.1).
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/airo-mobile-ct-system-0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Feb 2024