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Tempus pro monitor

Official notice

25 Apr 2025

Last checked

25 Apr 2025

Critical riskHealth Canada

An official Health Canada notice concerns Tempus pro monitor. I. The device may fail to startup normally, freeze, or reboot. Error messages may be displayed, resulting in the device becoming inoperable. These issues could occur during startup or clinical use in the following ways: The Tempus Pro monitor may freeze at the startup screen, display an "mpm application" software error message, or may show an "attention-restart required" message. The Tempus Pro monitor may freeze and automatically reboot either when the user starts the process of recording a 12-lead ECG (by pressing the "start record" button) or after the 12-lead has been recorded when the user presses another button in the 12-lead interface, such as "print" or "view interpretation". The Tempus Pro monitor may automatically reboot during an intermittent connection with the Tempus Pro smart mount. Ii. 12-lead ECG measurements of the Tempus Pro monitor, generated by the standard (louvain) algorithm, could produce inaccurate ECG rhythm and morphology statements. This issue impacts sw versions before vx.36. Recall start date: April 21, 2025 Published 2025-04-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77326

Official notice

2025-04-25

The hazard

I. The device may fail to startup normally, freeze, or reboot. Error messages may be displayed, resulting in the device becoming inoperable. These issues could occur during startup or clinical use in the following ways: The Tempus Pro monitor may freeze at the startup screen, display an "mpm application" software error message, or may show an "attention-restart required" message. The Tempus Pro monitor may freeze and automatically reboot either when the user starts the process of recording a 12-lead ECG (by pressing the "start record" button) or after the 12-lead has been recorded when the user presses another button in the 12-lead interface, such as "print" or "view interpretation". The Tempus Pro monitor may automatically reboot during an intermittent connection with the Tempus Pro smart mount. Ii. 12-lead ECG measurements of the Tempus Pro monitor, generated by the standard (louvain) algorithm, could produce inaccurate ECG rhythm and morphology statements. This issue impacts sw versions before vx.36. Recall start date: April 21, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77326

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Affected products

Product 1

Affected products - Tempus Pro, Lot or serial number - Not applicable., Model or catalog number - 00-1026-R 00-1007-R 00-1024-R

Risk / hazard

I. The device may fail to startup normally, freeze, or reboot. Error messages may be displayed, resulting in the device becoming inoperable. These issues could occur during startup or clinical use in the following ways: The Tempus Pro monitor may freeze at the startup screen, display an "mpm application" software error message, or may show an "attention-restart required" message. The Tempus Pro monitor may freeze and automatically reboot either when the user starts the process of recording a 12-lead ECG (by pressing the "start record" button) or after the 12-lead has been recorded when the user presses another button in the 12-lead interface, such as "print" or "view interpretation". The Tempus Pro monitor may automatically reboot during an intermittent connection with the Tempus Pro smart mount. Ii. 12-lead ECG measurements of the Tempus Pro monitor, generated by the standard (louvain) algorithm, could produce inaccurate ECG rhythm and morphology statements. This issue impacts sw versions before vx.36. Recall start date: April 21, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Remote Diagnostic, Tempus Pro Monitor.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

77326

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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