Philips Electronics North America Corporation recalls Philips IntelliVue Measurement Module X1 Model: M3001A
- Recall date
- January 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0853-2016
- 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 Measurement Module X1 Model: M3001A
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