FDA-Device2025-12-10Class IIPROCESSING DEFECT
IntelliVue Patient Monitor MX600. Product Number: 865242.
Hazard
Potential issue where the IntelliVue monitors did not alarm.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
1,913,441 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
IntelliVue Patient Monitor MX600. Product Number: 865242.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0866-2026More Philips recalls
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- FDA-Device2026-09-09Philips Ingenuity CT and related systems recalled for unintended radiation issue
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- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
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