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 Mobius Imaging Airo Mobile Ct System [MOBICT-32; All lots] [HKMD No.: 220345].
According to Health Canada, the manufacturer is notifying airo truct customers that we will be highlighting certain information that is already in the airo truct user manual on labels affixed to the airo truct unit itself. Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an airo truct unit in reverse. The airo truct unit at issue did not experience a malfunction.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/airo-mobile-ct-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Dec 2022