Philips Electronics North America Corporation recalls Philips IntelliVue Module Measurement X2 Model: M3002A

Recall date

January 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0854-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Icelan…

Why it was recalled

The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips IntelliVue Module Measurement X2 Model: M3002A