Device Recall Philips IntelliVue MX4O WLAN Patient Wearable Monitor

The following product number and Exchange part numbers containing the combination of HW Revision C.01 .01 with SW Revisions B.05 or B.06 of the Philips IntelliVue MX4O Patient Wearable Monitor

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kingdom

Philips IntelliVue MX4O WLAN Patient Wearable Monitor || Product: 865352 || Exchange part (service numbers): || 453564615311 TELE PWM,802.lla/b/g,ECG only, US only || 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02;, US only || 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 MX4O 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 MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.