CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

IntelliVue Patient Monitor MX400 recalled by Philips North America

Philips North America is recalling IntelliVue Patient Monitor MX400, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 866060; UDI-DI: 00884838038752; All Serial No.

Quantity recalled1,913,441 units

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-0862-2026
FDA event ID: 97917
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Oct 2025
FDA classified: 2 Dec 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

31 Oct 2025	Recall initiated by company
2 Dec 2025	Classified by FDA	+32 days
10 Dec 2025	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

Potential issue where the IntelliVue monitors did not alarm.

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

IntelliVue Patient Monitor MX400. Product Number: 866060.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Equat Guinea, Estonia, Ethiopia, Faroe Islands, Finland, French Polynesia, France, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea Rep, Kuwait, Lao, Latvia, Lebanon, Lesotho, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Ant, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, , R¿union, Romania, Russia, Saint Vincent, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre Mqln, Suriname, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Tajikistan, Thailand, Trinidad Tobago, Tunisia, T¿rkiye, Turkmenistan, Uganda, Ukraine, United Kingdom, United States, Uruguay, Utd Arab Emir, Uzbekistan, Venezuela, Viet Nam, Virgin Isl (Br), Virgin Isl (US), White Russia, Yemen, Zambia, Zimbabwe.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Potential issue where the IntelliVue monitors did not alarm.

Which lots are affected?

Product Number: 866060; UDI-DI: 00884838038752; All Serial No.

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

Other products in this recall event

21 other products · FDA event 97917

This product is part of a recall event; the main page for the event is IntelliVue MP90 recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025	CLASS II	IntelliVue MP90 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP30 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX800 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX700 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX500 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX850 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP2 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP50 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP80 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX100 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP40 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Multi Measurement Server X2 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP60 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP5 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP20 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX600 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Multi-Measurement Module X3 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX550 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX750 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue Patient Monitor MX450 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
10 Dec 2025	CLASS II	IntelliVue MP70 recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

More recalls from Philips North America

All 558

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide