FDA recall Z-1695-2019

Philips North America, LLC · Class II · device

Product

IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - 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 .

Distribution

Worldwide distribution - US Nationwide and to 71 countries.

Key facts

Status
Ongoing
Initiation date
2019-03-28
Report date
2019-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2019