Cardiac Workstation 7000; Model Number: 860441;
FDA Recall #Z-0166-2026 — Class II — September 12, 2025
Product Description
Cardiac Workstation 7000; Model Number: 860441;
Reason for Recall
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Recalling Firm
Philips North America — Cambridge, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
29 units
Distribution
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Code Information
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.