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.
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Cardiac Workstation 7000; Model Number: 860441;
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
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 →