Company:Philips Electronics North America Corporation
Date of Enforcement Report 4/12/2017
Class lI:
PRODUCT
Philips IntelliVue MX4O WLAN Patient Wearable MonitorProduct: 865352Exchange part (service numbers):453564615311 TELE PWM,802.lla/b/g,ECG only, US only453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US onlyProduct Usage:Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Recall Number Z-1707-2017
REASON
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 3/6/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
2648
DISTRIBUTION
Nationwide and Internationally
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