FDA-Device2026-08-26Class IIPROCESSING DEFECT
Philips Cardiac Workstation 7000 recalled for inaccurate heart rate readings
What this means
The Philips Cardiac Workstation 7000 (Product Number 860441) may intermittently display inaccurate information about a patient's native heart rate. This could affect the reliability of cardiac data used by healthcare providers during diagnosis and monitoring.
- Contact Philips North America if you operate one of the affected devices (check your serial number against the provided list).
- Do not rely solely on this device for heart rate measurements until you receive guidance from Philips or your healthcare provider.
- Continue using alternative methods to monitor patient heart rate as directed by your clinical team.
The agency's original wording
Hazard
Device will intermittently provide inaccurate data related to native heart rate.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of 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, United Kingdom.
Affected count
1,810 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Cardiac Workstation 7000. Product Number: 860441.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2956-2026More Philips recalls
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