Recall Z-1694-2019— Philips North America, LLC

Name: FDA recall Z-1694-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-28

Class II · Ongoing

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-03-28. It names one FDA 510(k) clearance: K113125. 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.. 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 ..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-03-28
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113125 — INTELLIVUE MX40 PATIENT MONITORPhilips Medical Systems·cleared 2011-11-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.