Health product recall

Tempus Pro

Last updated

Summary

Product
Tempus Pro
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Tempus Pro Not applicable. 00-1007-R

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Remote Diagnostic Technologies Limited

Ascent 1, Farnborough, Great Britain, GU14 6XW

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-73129