Health Canada Recalls Philips Cardiac Workstation Over Inaccurate Heart Rate Data

Health Canada has issued a Type II medical device recall for the Philips Medizin Systeme Boblingen Gmbh Cardiac Workstation after reports that the device can intermittently display inaccurate patient heart rate and ECG data. The issue affects the Cardiac Workstation 5000 and 7000 models and is linked to the Wired Patient Interface Module (PIM) accessory used with the systems.

What Products Are Being Recalled?

• Cardiac Workstation 5000 – Model or catalogue number 860439
• Cardiac Workstation 7000 – Model or catalogue number 860441

No specific lot or serial numbers are listed for the affected units, as the recall notice states lot or serial number information is ‘not applicable’ for these models. The devices are manufactured by Philips Medizin Systeme Boblingen Gmbh, based in Boblingen, Germany.

Why Was This Recall Issued?

According to Health Canada, the cardiac workstation can intermittently provide inaccurate data related to a patient’s native heart rate. In several instances, healthcare providers recognized that a secondary review was needed because the patient’s clinical presentation and symptoms did not match the elevated heart rate shown on the device display. While an unusually high heart rate reading may alert clinicians that something is wrong, the underlying issue can also affect the accuracy of the entire ECG report, including waveform data, measurements, and interpretive statements.

Health Canada explains that the problem is tied to the Wired PIM accessory used with the Cardiac Workstation. In rare cases, when the workstation is returned from Standby mode, the system may fail to correctly set the ECG sampling rate in the Wired PIM. This malfunction can lead to inaccurate ECG waveform readings and faulty interpretation of cardiac data.

Who Is Affected?

This recall is directed at the healthcare sector rather than the general public. Hospitals, clinics, and other medical facilities in Canada that use the Cardiac Workstation 5000 or 7000 with the Wired PIM accessory for patient cardiac monitoring may be affected. Because the workstation is used to monitor heart rate and generate ECG reports, inaccurate readings could potentially affect clinical decision-making for patients undergoing cardiac monitoring.

What Should You Do?

Health Canada advises affected healthcare facilities and providers to contact the manufacturer, Philips Medizin Systeme Boblingen Gmbh, if they require additional information regarding this recall. Clinical staff using the Cardiac Workstation 5000 or 7000 should remain alert to discrepancies between displayed heart rate readings and a patient’s actual clinical presentation, and should perform secondary review of ECG data where inconsistencies are suspected. Facilities can also report any related health or safety concerns directly to Health Canada through its official reporting channel.

Official Statement

Health Canada published this alert on 2026-07-16, with an official recall date of 2026-07-07 and identification number RA-82332. The recall is classified as a Type II health product recall under the category of Health products – Medical devices – Cardiovascular, with an audience designation of Healthcare.