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 Drägerwerk AG & Co. KGaA Zeus Infinity Empowered [Model or Catalog Number: MK04000] [HKMD No.: 240257].
According to Health Canada, the Zeus IE features two gas measurement modules, a patient gas analyzer, and a system gas analyzer. Both contain a pump which is sampling the gas to be analyzed. This sampling pump has shown an increased failure rate, which might lead to different effects during use of the Zeus IE. The effects depend on the therapy settings.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/zeus-infinity-empowered
If you are in possession of the affected products, please contact your supplier for necessary actions.
Updated on 12 December 2024