Philips North America, LLC recalls IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: U…

Recall date

March 28, 2019

Source

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

Recall number

Z-1692-2019

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide distribution - US Nationwide and to 71 countries.

Why it was recalled

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

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

What was recalled

IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.