Z-1707-2017Class II

Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers)...

Name: Z-1707-2017 Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers)...
Creator: Philips Electronics North America Corporation
Published: 2017-03-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-03-06 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only... on 2017-03-06. FDA classified it as Class II and gives the reason as "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]". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1707-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-06
Posted: 2017-04-04
Terminated: 2018-05-25
Recalling firm: Philips North America LLC
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.
Product code: DSI Detector And Alarm, Arrhythmia
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]
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1707-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1707-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

Product code DSI

K113125Class IIIntellivue Mx40 Patient MonitorPhilips Medical Systems / cleared 2011-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)