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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue MX4O WLAN Patient Wearable Monitor

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  Class 2 Device Recall Philips IntelliVue MX4O WLAN Patient Wearable Monitor see related information
Date Initiated by Firm March 06, 2017
Create Date April 04, 2017
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-1707-2017
Recall Event ID 76656
510(K)Number K113125  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product 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.
Code Information 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
Recalling Firm/
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
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]
FDA Determined
Cause 2
Software design
Action Philips issued Field Safety Notice on 3/6/17. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer .Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: When a No Data Tele INOP alert is displayed on a Philips IntelliVue Information Center iX (PIIC iX), check the MX40 as directed in the PIIC iX B.01 IFU, page 87. If the MX40 is in the Coverage Area, remove the battery, and reinsert the battery. If the MX40 is not in the Coverage Area, place the sector in the PIIC iX in standby as directed in the MX40 B.06 IFU, page 53, or return the patient and MX40 to the Coverage Area. Philips is releasing a software upgrade B.06.18 for affected Philips IntelliVue MX40 Patient Wearable Monitors. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade
Quantity in Commerce 2648
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS