Recall Monitor
Health Products

Cardiac Workstation

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Cardiac Workstation
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Cardiac Workstation 5000Not applicable.860439
Cardiac Workstation 7000Not 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.

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