Cl II Philips IntelliVue Patient Wearable Monitor

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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