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 GE Healthcare Finland Oy CARESCAPE Monitoring System [CARESCAPE B650 (Model or catalog number: MBB323, MBB313), CARESCAPE Canvas (Model or catalog number: 5876727), CARESCAPE Canvas Smart Display (Model or catalog number: 5897060), CARESCAPE Monitor B850 (Model or catalog number: 2095802-001, MBC313, MBC323)] [HKMD No.: 140296, 240096].
According to Health Canada, there is a potential for loss of monitoring if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/carescape-monitoring-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 May 2024