[mdr] Pagewriter Tc35 Cardiograph; Cw 5000; Cw7000
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- [MDR] PageWriter TC35 Cardiograph; CW 5000; CW7000. [Device]. Model: Cardiac Workstation 5000. Affected: Product Number - 860439
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-27
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/2a570c1b-c07e-463c-b776-1d2f281df6ba