CanadaThe Philips Cardiac Workstation models 5000 (model/catalogue 860439) and 7000 (model/catalogue 860441) are affected. They can intermittently provide an inaccurate native heart rate and may affect the entire ECG report (waveform data, measurements and interpretive statements) because the Wired Patient Interface Module (PIM) may not set the ECG sampling rate correctly when the workstation returns from Standby. Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany, 71034.
How to identify it
Affected products: Cardiac Workstation 5000; Lot or serial number: Not applicable.; Model or catalogue number: 860439
Affected products: Cardiac Workstation 7000; Lot or serial number: Not applicable.; Model or catalogue number: 860441
The hazard
The cardiac workstation can intermittently provide inaccurate data related to the patient's native heart rate. Healthcare providers were able to recognize that secondary review was needed because the patient’s clinical presentation and symptoms were not consistent with the elevated heart rate displayed by the Cardiac Workstation. Although the elevated heart rate may serve as an indicator to the clinician that the data is inaccurate, the issue also impacts the accuracy of the entire ECG report, including waveform data, measurements, and interpretive statements. This issue is related to the Wired Patient Interface Module 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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)