Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00432-1 |
Product Name/Description |
Tempus LS with serial numbers prior to 7021.002867
UDI: 07613365001693
Model Number: 3.940590 Tempus LS Base unit
ARTG 362650 (Philips Electronics Australia Ltd - Physiologic-monitoring defibrillation system) |
Recall Action Level |
Retail |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
7/06/2024 |
Responsible Entity |
|
Reason/Issue |
SCHILLER AG has identified missing information in the instructions for use for the Tempus LS. The information was missing that simultaneous ECG measurements with multiple devices on the same patient may lead to distortions of the ECG signal.
Distortions may lead to no or ineffective pacing or no or inappropriate defibrillation pulse. |
Recall Action |
Product Defect Correction |
Recall Action Instructions |
SCHILLER has updated the User/Operator Manual (Instructions for Use (IFU)) with the information that two ECG amplifiers must not be connected to the same patient at the same time. The updated User/Operator Manual (Instructions for Use (IFU)) can be downloaded by searching “Tempus LS User-Operator Manual” at Philips.com/IFU. |
Contact Information |
1800 251 400 - Philips Service Delivery Team |