FDAClass IIOctober 22, 2025

Cardiac Workstation 7000 recall

Cardiac Workstation 7000; Model Number: 860441;

Why was Cardiac Workstation 7000 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Cardiac Workstation 7000; Model Number: 860441;
Recalling firm
Philips North America
Quantity
29 units
Distribution
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls