| TGA Action ID |
RC-2025-RN-00471-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Tempus Pro Monitor
Unique Device Identifiers:
00-1004-R (05060472442901)
00-1007-R (05060472442918)
00-1024-R (05060472441027)
00-1026-R (05060472441058)
The failure to startup normally, freeze, or reboot can affect all Tempus Pro Monitors using SW versions prior to vx.40.
Inaccurate 12-lead ECG interpretations affect only devices with SW version before vx.36 and the standard (Louvain) algorithm. |
| ARTG Number |
315260 |
| Unique Device Identifier (UDI) |
00-1004-R (05060472442901), 00-1007-R (05060472442918) , 00-1024-R (05060472441027), 00-1026-R (05060472441058) |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified 2 problems:
I. The device may fail to startup normally, freeze, or reboot. Error messages may be displayed, resulting in the device becoming inoperable. These problems could occur during startup or clinical use in the following ways:
o 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.
o 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’.
o 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.
Philips has not received any reports of patient harm related to these problems.
Updated 06/11/2025: The solution has been released in software (SW) version vx.40. |
| Instructions for Customers/Users |
Philips has developed a software update to resolve these problems that is expected to be available in Q3 2025. Customers will be contacted by Philips to implement the software update.
In the meantime, customers may continue to use their device, however Philips advises that they take the following precautions:
I. The User/Operator Manual (Warning (in Chapter 2, Getting started) provides precautions and warnings on maintaining appropriate power or battery supply, which may reduce the risk of occurrence of an “MPM Application” software error message.
II. If it is confirmed that the Tempus Pro has the standard (Louvain) algorithm, continue to follow the User/Operator Manual, (Warning (in Chapter 6, Taking medical readings) which warns users to not make evaluations based solely on interpretation statements from the algorithm.
Updated 06/11/2025: The solution for FSN-2024-CC-EC-023 (Tempus Pro Software Problems) has been released in software (SW) version vx.40. Philips will contact customers to arrange the update under FCO86700012. |
| Action Commencement Date |
15/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |