April 12, 2017
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...
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Company:Philips VisicuDate of Enforcement Report 4/12/2017 Class lI: PRODUCT eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient...
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