| TGA Action ID |
RC-2025-RN-00473-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Tempus Pro Monitor
Part number: 01-1004-R, 00-1007-R. 00-1024-R and 00-1026-R
Video Laryngoscope
Part number: 01-2044 |
| ARTG Number |
315260 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A complaint was received and subsequent investigation found that, when a user connects the Video Laryngoscope (VL) to the Tempus Pro Monitor during boot-up, the VL screen is displayed instead of the expected patient details dialog screen. If the user attempts to capture an image (to clear the screen), an error dialog screen is shown that asks the user to restart the device.
Philips is updating the IFU to include warning wordings.
Update 06/11/2025: The updated documents can be downloaded on the website. |
| Instructions for Customers/Users |
Philips is updating the Tempus Pro User/Operator Manual and the Tempus Pro Video Laryngoscope Supplement Guide to include the following Warning:
DO NOT connect the video laryngoscope USB probe to the Tempus Pro during device boot-up.
Once ‘Patient Details’ dialog appears, enter patient data then plug in the video laryngoscope USB probe.
Additionally, the video laryngoscope start-up steps will be updated to plug the laryngoscope into either of the two USB ports on the Tempus Pro after boot-up sequence is complete.
Philips will notify customers again when the updated Tempus Pro User/Operator Manual and Tempus Pro Video Laryngoscope Supplement Guide is available for download.
Update 06/11/2025: The updated IFU can be downloaded on the website.
This action has been closed out on 19/06/2026 |
| Action Commencement Date |
20/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |