Use caution Medical device recall · FDA · Published October 31, 2025

Philips IntelliVue MP90 Monitors May Not Alarm - Recall

Philips recalls IntelliVue MP90 monitors (product number M801: M8010A) due to potential failure to alarm. Affected units may not alert users to critical health changes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0858-2026Medical device Philips ›

Use caution until it’s fixed

Potential issue where the IntelliVue monitors did not alarm.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling IntelliVue MP90 monitors that may not alarm properly. This could mean critical health changes go unnoticed, risking serious injury or death for users. Read more at govinfonow.com/recall/50829-philips-intellivue-mp90-monitors-may-not-alarm-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/50829-philips-intellivue-mp90-monitors-may-not-alarm-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0858-2026

Cite this page

“Philips IntelliVue MP90 Monitors May Not Alarm - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50829-philips-intellivue-mp90-monitors-may-not-alarm-recall. Based on FDA recall #Z-0858-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0858-2026%22&limit=1).

The FDA announced on Oct. 31, 2025, that Philips North America LLC is voluntarily recalling its IntelliVue MP90 patient monitors due to a potential issue where the devices may not alarm. The agency issued recall number Z-0858-2026 for the Class II device.

How to tell if you have it

Brand: Philips
Product: IntelliVue MP90
Product Number: M8010A
UDI-DI: 00884838000223
Units affected: 1,913,441

The hazard

According to the FDA, the hazard involves a potential issue where the IntelliVue monitors did not alarm. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent Philips recalls include a software issue that may terminate scans in the Philips Achieva 3.0T MRI (Aug. 21, 2026), a Spectral CT 7500 crash risk (Aug. 18, 2026), and an unintended radiation risk in Brilliance CT 64 scanners (Aug. 7, 2026). Other recent recalls of similar products include the Philips Patient Information Center iX Software upgrade warning (Dec. 22, 2025) and GE Medical Systems Portrait Core Services and Compute software patient monitoring risks (July 20, 2026).

How to tell if you have this one

Check for product number M8010A on the monitor. Units sold with serial numbers starting with 'M8010A' are affected. The UDI-DI code 00884838000223 is also associated with this recall.

Brand
Philips
Category
Medical device

FDA recall event · 22 products

All 22 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots
Z-0849-2026	IntelliVue MP2. Product Number: M8102A.; Product Number: M8102A; UDI-DI: 00884838000278; All Serial No.
Z-0850-2026	IntelliVue MP5. Product Number: M8105A.; Product Number: M8105A; UDI-DI: 00884838000230; All Serial No.
Z-0851-2026	IntelliVue MP20. Product Number: M8001A.; Product Number: M8001A; UDI-DI: 00884838000193; All Serial No.
Z-0852-2026	IntelliVue MP30. Product Number: M8002A.; Product Number: M8002A; UDI-DI: 00884838000155; All Serial No.
Z-0853-2026	IntelliVue MP40. Product Number: M8003A.; Product Number: M8003A; UDI-DI: 00884838000162; All Serial No.
Z-0854-2026	IntelliVue MP50. Product Number: M8004A.; Product Number: M8004A; UDI-DI: 00884838000179; All Serial No.
Z-0855-2026	IntelliVue MP60. Product Number: M8005A.; Product Number: M8005A; UDI-DI: 00884838000186; All Serial No.
Z-0856-2026	IntelliVue MP70. Product Number: M8007A.; Product Number: M8007A; UDI-DI: 00884838000209; All Serial No.
Z-0857-2026	IntelliVue MP80. Product Number: M8008A.; Product Number: M8008A; UDI-DI: 00884838000216; All Serial No.
Z-0858-2026	IntelliVue MP90. Product Number: M8010A.; Product Number: M8010A; UDI-DI: 00884838000223; All Serial No.
Z-0859-2026	IntelliVue Multi Measurement Server X2. Product Number: M3002A.; Product Number: M3002A; UDI-DI: 00884838000261; All Serial No.
Z-0860-2026	IntelliVue Multi-Measurement Module X3. Product Number: 867030.; Product Number: 867030; UDI-DI: 00884838082588; All Serial No.
Z-0861-2026	IntelliVue Patient Monitor MX100. Product Number: 867033.; Product Number: 867033; UDI-DI: 00884838082595; All Serial No.
Z-0862-2026	IntelliVue Patient Monitor MX400. Product Number: 866060.; Product Number: 866060; UDI-DI: 00884838038752; All Serial No.
Z-0863-2026	IntelliVue Patient Monitor MX450. Product Number: 866062.; Product Number: 866062; UDI-DI: 00884838038769; All Serial No.
Z-0864-2026	IntelliVue Patient Monitor MX500. Product Number: 866064.; Product Number: 866064; UDI-DI: 00884838038776; All Serial No.
Z-0865-2026	IntelliVue Patient Monitor MX550. Product Number: 866066.; Product Number: 866066; UDI-DI: 00884838038783; All Serial No.
Z-0866-2026	IntelliVue Patient Monitor MX600. Product Number: 865242.; Product Number: 865242; UDI-DI: 00884838029095; All Serial No.
Z-0867-2026	IntelliVue Patient Monitor MX700. Product Number: 865241.; Product Number: 865241; UDI-DI: 00884838029088; All Serial No.
Z-0868-2026	IntelliVue Patient Monitor MX750. Product Number: 866471.; Product Number: 866471; UDI-DI: 00884838083332; All Serial No.
Z-0869-2026	IntelliVue Patient Monitor MX800. Product Number: 865240.; Product Number: 865240; UDI-DI: 00884838020733; All Serial No.
Z-0870-2026	IntelliVue Patient Monitor MX850. Product Number: 866470.; Product Number: 866470; UDI-DI: 00884838070790; All Serial No.

Based on the official FDA remedy

What to do — step by step

Check Monitor Functionality
Test if the monitor alarms when critical health changes occur, such as rapid heart rate or low blood pressure.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Oct 31, 2025Firm started the recall
Dec 2, 2025FDA classified it Class II
Dec 10, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50829-philips-intellivue-mp90-monitors-may-not-alarm-recall">Philips IntelliVue MP90 Monitors May Not Alarm - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0858-2026 (October 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0858-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.