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 Philips Medizin Systeme Böblingen GmbH IntelliVue MX550 Patient Monitor [Model or catalog number: 866066] [HKMD No.: 140224].
According to Health Canada, the manufacturer became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the device's electromagnetic immunity and emission. Degraded electromagnetic immunity can cause the monitor to generate unreadable or unusable waveforms, potentially leading to incorrect/delayed patient treatment. Excessive or unintended electromagnetic emissions can also negatively impact the function of equipment in the vicinity of the patient monitor, potentially leading to delayed procedure. Although unlikely, these scenarios could potentially result in patient harm.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/intellivue-mx550-patient-monitor
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Sep 2024