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Cardiac Workstation 5000; Model Number: 860439;

FDA Recall #Z-0165-2026 — Class II — September 12, 2025

Recall #Z-0165-2026 Date: September 12, 2025 Classification: Class II Status: Ongoing

Product Description

Cardiac Workstation 5000; Model Number: 860439;

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

28 units

Distribution

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

Code Information

Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:

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.

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