← FDA ENFORCEMENT
Z-0165-2026Class II
Philips North America
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Philips North America
Product type
Device
Status
Ongoing
Report date
2025-10-22
Distribution
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Firm state
MA
Product quantity
28 units
Initiated by
Voluntary: Firm initiated
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.
Product description
Cardiac Workstation 5000; Model Number: 860439;
Code / lot info
Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →