FDAHealthSeptember 12, 2025

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

⚠️ Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: September 12, 2025

US Nationwide distribution in the states of CA, IA, TN, TX, VA.

What's affected?

Product: Cardiac Workstation 7000; Model Number: 860441;
Brand: Philips North America
Lot code: Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;

Additional details

Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 29 units.

View original FDA notice →

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