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Philips North America: Cardiac Workstation 7000; Model Number: 860441;

Medical DevicesSource: FDA (device) · Date: 2025-10-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America
Product
Cardiac Workstation 7000; Model Number: 860441;
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Recall initiated
2025-09-12
Code info
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Product quantity
29 units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
97612
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