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Health Canada16 Jul 2026

Cardiac Workstation

Health Canada published a recall notice for Cardiac Workstation on 16 Jul 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.

Recall

The recall notice

Issued by
Health Canada
Issued
16 Jul 2026
Recall type
Health product recall
Companies
Philips Medizin Systeme Boblingen GmbhHewlett-Packard Strasse 2, Boblingen, Germany, 71034
Official source
Health Canada: the notice at its source

The latest from Health CanadaEvery warning and recall in Canada

Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.

The notice as issued

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: 2026-07-16 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

Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.

The record around this notice