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.
FDA Recall Z-1707-2017 · Posted None
Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeDSI
Date Initiated2017-03-06
Date Terminated2018-05-25
Product Quantity2648
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]
Firm 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
Root Cause
Software design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.