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Recall Observatory FDA recall evidence

Device product

Cardiac Workstation 7000; Model Number: 860441;

Z-0166-2026

September 12, 2025

Class II

Product summary

Firm
Philips North America
Event
Event 97612
Status
Ongoing
Classification
Class II
Quantity
29 units
Official record key
device-enforcement:Z-0166-2026

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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