Philips North America Llc: Electrocardiograph

Recalling firm
Philips North America Llc
Product
Cardiac Workstation 7000. Product Number: 860441.
Reason
Device will intermittently provide inaccurate data related to native heart rate.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-07-01
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
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,...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0899925f-3e64-4e85-b512-a8814a452cab