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 Cardiac Science Corporation Powerheart AED G5 Semi-Automatic and Powerheart AED G5 Semi-Automatic With CPR Assist [HKMD number: 150366].
According to Health Canada, the G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to manufacturer’s attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button. This may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/powerheart-aed-g5-semi-automatic-and-powerheart-aed-g5-semi-automatic-cpr-assist
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Jun 2024