FDA-Device2025-10-22Class II
Cardiac Workstation 7000; Model Number: 860441;
Philips North America
Hazard
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Sold states
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Affected count
29 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Cardiac Workstation 7000; Model Number: 860441;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0166-2026Don't want to check this manually?
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