medical Class II Updated 2019-04-03

Philips North America, LLC recalls Lithium-ion Rechargeable Batteries for the Philips MX40 Wear

Recalled Product

Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be 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. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.


Hazard / Issue

Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 2018-28
View official government recall

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