FDAFDA · Food and drugs·Recall number Z-0858-2026
IntelliVue MP90. Product Number: M8010A.
Published December 10, 2025 · Recall initiated: October 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential issue where the IntelliVue monitors did not alarm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- 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.
- Lot
- Product Number: M8010A; UDI-DI: 00884838000223; All Serial No.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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