FDA-Device2026-08-26Class IIPROCESSING DEFECT
Philips Cardiac Workstation 5000 recalled for inaccurate heart rate data
What this means
The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.
- Contact Philips North America if you operate an affected device (check your serial number against the list provided by Philips)
- Do not rely solely on this device for heart rate measurements until you receive further guidance from Philips
- Follow any corrective instructions or firmware updates issued by Philips
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
796 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Cardiac Workstation 5000. Product Number: 860439.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2955-2026More Philips recalls
- FDA-Device2026-09-30Philips Ingenia 3.0T MRI systems recalled for software image reconstruction failure
- FDA-Device2026-09-30Philips SmartPath MRI software recalled for exam termination risk
- FDA-Device2026-09-30Philips Achieva 1.5T MRI systems recalled for software issue causing exam termination
- FDA-Device2026-09-30Philips Ingenia Ambition MRI systems recalled for software crash during image processing
- FDA-Device2026-09-30Philips Intera 1.5T MRI systems recalled for software examination termination risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.