Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37147 |
| Brand Name: | [MDR] PageWriter TC35 Cardiograph; CW 5000; CW7000 |
| Model: | Cardiac Workstation 5000 |
| Affected: | Product Number - 860439 |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medizin Systeme Boblingen GmbH |
| Issue: | The manufacturer received multiple complaints that the Cardiac Workstation may intermittently display an inaccurate, often elevated, native heart rate. While clinicians were generally able to identify the discrepancy because it did not match the patient's clinical presentation, the issue can affect the accuracy of the entire ECG report, including waveform data, measurements, and interpretive statements. The problem is linked to the Wired PIM accessory and may occur, in rare cases, when the Cardiac Workstation exits Standby mode and fails to correctly set the ECG sampling rate. This can result in inaccurate ECG waveform display and interpretation. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/7/2026 |
