Tempus Pro
Last updated
Summary
Product
Tempus Pro
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Tempus Pro | Not applicable. | 00-1026-R |
| Tempus Pro | Not applicable. | 00-1004-R |
| Tempus Pro | Not applicable. | 00-1007-R |
| Tempus Pro | Not 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.
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, United Kingdom, GU14 6XW |
Published by
Health Canada
Audience
General public
Recall class
Type II
Recall date
Identification number
RA-81341
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