Health product recall

Cardiac Workstation

Last updated

Summary

Product
Cardiac Workstation
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Cardiac Workstation 5000 Not applicable. 860439
Cardiac Workstation 7000 Not applicable. 860441

Issue

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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Philips Medizin Systeme Boblingen Gmbh

Hewlett-Packard Strasse 2, Boblingen, Germany, 71034

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82332

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