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Recall Observatory FDA recall evidence

Device product

IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 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.

Z-1694-2019

March 28, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 82696
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1694-2019

Official wording

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

Code information: All revision B.X versions are affected.

Distribution pattern: Worldwide distribution - US Nationwide and to 71 countries.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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