Philips recalls Cardiac Workstation systems due to software issue—users urged to follow new guidance
Philips has alerted customers about a new recall involving some of its Cardiac Workstation systems. No returns are necessary, the company noted, but there are certain steps clinicians should take to avoid any issues.
This recall includes nearly 800 Cardiac Workstation 5000 systems, and more than 1,800 Cardiac Workstation 7000 systems. These cardiographs help clinicians perform, access, view, analyze, store, share and manage electrocardiograms (ECGs) from a single workspace.
The recall was put in place after Philips received multiple reports of these systems providing inaccurate data on a patient’s native heart rate. While the user may catch the inaccuracy in the moment, there is a risk of the issue impacting the accuracy of entire ECG reports, including waveform data, measurements and interpretive statements.
The issue appears to occur intermittently when the devices are taken out of standby mode. To avoid any incidents, users should disable the automatic standby feature and avoid manually putting the systems in standby.
Philips warned customers about this potential software issue in an Urgent Medical Device Correction letter. The company will reach out again to arrange an upgrade to a newer version of the Cardiac Workstation software.
Affected systems were originally distributed to the United States, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.
The Cardiac Workstation 7000. Image courtesy of Philips.
No returns necessary—systems can still be used
The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall, which means there is a risk of “temporary or medically reversible adverse health consequences.” At this time, however, no adverse events have been reported.
Unlike many device recalls, these workstations to not need to be returned to the manufacturer. Clinicians can continue using them, but they are advised to review the new information provided by Philips.
Click here for more information from the FDA. These details were first shared online on Aug. 14.
Philips comments on Class II recall
A Philips spokesperson shared a statement on this recall with Cardiovascular Business:
Philips has intensified efforts to strengthen patient safety and quality across the company. We are methodically working through product quality at all levels and businesses in a multi-year program. We act fast on postmarket surveillance signals, proactively issuing corrections, updates or recalls when we identify potential issues.
In July 2026, the company issued a notice to customers of the Cardiac Workstation 5000 and 7000 Systems regarding a potential issue where affected units may intermittently provide inaccurate data related to a patient’s native heart rate.
At the time of this notification, Philips has not received any reports of adverse events associated with this issue. Customers may continue to use affected systems in accordance with their Instructions for Use (IFU) and the guidance in the notice.
To address this issue, Philips will upgrade affected units to the Cardiac Workstation Release 1.2.0.7.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.