Health Canada — Medical Devices · Canada · 2025-04-25 · Type I
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Reported risk: i. The device may fail to startup normally, freeze, or reboot. error messages may be displayed, resulting in the device becoming inoperable. These issues could occur during startup or clinical use in the following ways: The Tempus Pro monitor may freeze at the startup screen, display an "mpm application" software error message, or may show an "attention-restart required" message. The Tempus Pro monitor may freeze and automatically reboot either when the user starts the process of recording a 12-lead ECG (by pressing the "start record" button) or after the 12-lead has been recorded when the user presses another button in the 12-lead interface, such as "print" or "view interpretation". The Tempus Pro monitor may automatically reboot during an intermittent connection with the Tempus Pro smart mount. ii. 12-lead ECG measurements of the Tempus Pro monitor, generated by the standard (louvain) algorithm, could produce inaccurate ECG rhythm and morphology statements. This issue impacts sw versions before vx.36. Recall start date: April 21, 2025
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