CLASS II Device recall · Reported 12 Apr 2017 · FDA Enforcement Report

865352 Exchange part (service numbers) recalled

Philips Electronics North America is recalling 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US, distributed nationwide in the US. The recall was initiated on 6 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe 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

Quantity recalled2648

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1707-2017
FDA event ID: 76656
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Mar 2017
FDA classified: 4 Apr 2017
Reported: 12 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

6 Mar 2017	Recall initiated by company
4 Apr 2017	Classified by FDA	+29 days
12 Apr 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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]

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US recalled?

Yes. Philips Electronics North America recalled 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US on 6 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1707-2017.

Why was it recalled?

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]

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Electronics North America

All 160

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Device	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide
24 Oct 2018Device	CLASS II	Philips HeartStart FR3 Defibrillator recalled	Philips Electronics North America	Sterility	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper F010, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide