United StatesIntelliVue patient monitors, including models such as IntelliVue MP2 (Product Number M8102A), MP5 (M8105A), MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), IntelliVue Multi Measurement Server X2 (M3002A) and other IntelliVue models (listed with UDI‑DI codes and all serial numbers), are affected. They were recalled because of a potential issue where the IntelliVue monitors did not alarm.
What's being recalled
IntelliVue MP2. Product Number: M8102A.
IntelliVue MP5. Product Number: M8105A.
IntelliVue MP20. Product Number: M8001A.
IntelliVue MP30. Product Number: M8002A.
IntelliVue MP40. Product Number: M8003A.
IntelliVue MP50. Product Number: M8004A.
IntelliVue MP60. Product Number: M8005A.
IntelliVue MP70. Product Number: M8007A.
IntelliVue MP80. Product Number: M8008A.
IntelliVue MP90. Product Number: M8010A.
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
IntelliVue Patient Monitor MX100. Product Number: 867033.
IntelliVue Patient Monitor MX400. Product Number: 866060.
IntelliVue Patient Monitor MX450. Product Number: 866062.
And 7 more products.
Recalling firm: Philips North America Llc, Cambridge, MA, United States.
How to identify it
Product Number: M8102A; UDI-DI: 00884838000278; All Serial No. Product Number: M8105A; UDI-DI: 00884838000230; All Serial No. Product Number: M8001A; UDI-DI: 00884838000193; All Serial No. Product Number: M8002A; UDI-DI: 00884838000155; All Serial No. Product Number: M8003A; UDI-DI: 00884838000162; All Serial No. Product Number: M8004A; UDI-DI: 00884838000179; All Serial No. Product Number: M8005A; UDI-DI: 00884838000186; All Serial No. Product Number: M8007A; UDI-DI: 00884838000209; All Serial No. Product Number: M8008A; UDI-DI: 00884838000216; All Serial No. Product Number: M8010A; UDI-DI: 00884838000223; All Serial No. Product Number: M3002A; UDI-DI: 00884838000261; All Serial No. Product Number: 867030; UDI-DI: 00884838082588; All Serial No. Product Number: 867033; UDI-DI: 00884838082595; All Serial No. Product Number: 866060; UDI-DI: 00884838038752; All Serial No. Product Number: 866062; UDI-DI: 00884838038769; All Serial No. Product Number: 866064; UDI-DI: 00884838038776; All Serial No. Product Number: 866066; UDI-DI: 00884838038783; All Serial No. Product Number: 865242; UDI-DI: 00884838029095; All Serial No. Product Number: 865241; UDI-DI: 00884838029088; All Serial No. Product Number: 866471; UDI-DI: 00884838083332; All Serial No. Product Number: 865240; UDI-DI: 00884838020733; All Serial No. Product Number: 866470; UDI-DI: 00884838070790; All Serial No.
The hazard
Potential issue where the IntelliVue monitors did not alarm.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)