Health Canada — Medical Devices · Canada · 2023-03-10 · Type II
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Reported risk: During internal testing, regulatory compliance issues regarding fluid ingress and basic safety issues have been identified with the Tempus Pro monitor, ac mains power supply, and the vehicle adaptor. the tempus pro device's labeling indicates that the device is water and sand resistant to ip66 (dust and water ingress under pressure). However, testing revealed that the device does not meet the standards for fluid and particulate ingress. Additionally, there is a possibility of component overheating or unanticipated voltage emitted from device electrical components. Philips has not received any complaints associated with these issues since introducing the device into the market in 2013. Recall start date: February 27, 2023
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