CanadaThe Tempus Pro patient monitor (models 00-1026-R, 00-1004-R, 00-1007-R, 00-1024-R) is affected. The user manual references “invasive pressure” including intracranial pressure (ICP) and bladder pressure (BDR) channels, but those measurements on the Tempus Pro have not been tested or validated and the device is only cleared for invasive blood pressure (IBP). Contact the manufacturer if you require additional information.
What's being recalled
Companies: Remote Diagnostic Technologies Limited, Ascent 1, Farnborough, United Kingdom, GU14 6XW.
How to identify it
Affected products: Tempus Pro; Lot or serial number: Not applicable.; Model or catalogue number: 00-1026-R
Affected products: Tempus Pro; Lot or serial number: Not applicable.; Model or catalogue number: 00-1004-R
Affected products: Tempus Pro; Lot or serial number: Not applicable.; Model or catalogue number: 00-1007-R
Affected products: Tempus Pro; Lot or serial number: Not applicable.; Model or catalogue number: 00-1024-R
The hazard
The user/operator manual references the term 'invasive pressure', which includes intracranial pressure (ICP) and bladder pressure (BDR) as selectable channel labels.
However, these measurements on the Tempus Pro monitor have not been tested or validated for accuracy. The device is only cleared for invasive blood pressure (IBP) measurements.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)