| TGA Action ID |
RC-2026-RN-00551-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cardiac Workstation 5000 and 7000
Product Numbers: 860439 and 860441 |
| ARTG Number |
442310 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has received multiple complaints indicating that the Cardiac Workstation can intermittently provide inaccurate data related to the patient’s native heart rate.
This problem is related to the Wired PIM accessory used with the Cardiac Workstation. In rare cases, when the Cardiac Workstation is returned from Standby mode, the system may not set the ECG sampling rate in the Wired PIM correctly. This can cause the ECG waveform and interpretation to be inaccurate. MisinterpretionMisinterpretation of the data could cause a delay in recognition, assessment or evaluation of a cardiac condition. |
| Instructions for Customers/Users |
Philips will contact customers to arrange an upgrade to the Cardiac Workstation.
In the interim, customers should continue using the device, but disable the automatic “Standby” feature, and avoid manually putting the Cardiac Workstation in “Standby” mode to minimise inaccurate heart rate values from occurring. |
| Action Commencement Date |
23/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |