Recall Monitor
Health Products

Tempus Pro

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Tempus Pro
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Tempus ProNot applicable.00-1026-R
Tempus ProNot applicable.00-1004-R
Tempus ProNot applicable.00-1007-R
Tempus ProNot applicable.00-1024-R

Issue

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.

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