Philips North America — Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
⚠️ The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2025
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.
What's affected?
- Product
- Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
- Lot code
- Model Numbers (REF): (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003, 42023, 42024, 42029, 42078, 42217, 42246, 42375, 42402, 42408, 71044, 71348, 71774, 85146, 85645, 85663, 85668, 85675, 85677, 85680, 85685, 85687, 85694, 85698, 85705, 85713, (2) 3, 42069, 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85651, 85682, 85683, 85684, 85688, 85690, 85695, 85697, 85699, 85701, 85708, 85714;
Additional details
Model Numbers (REF): (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003, 42023, 42024, 42029, 42078, 42217, 42246, 42375, 42402, 42408, 71044, 71348, 71774, 85146, 85645, 85663, 85668, 85675, 85677, 85680, 85685, 85687, 85694, 85698, 85705, 85713, (2) 3, 42069, 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85651, 85682, 85683, 85684, 85688, 85690, 85695, 85697, 85699, 85701, 85708, 85714;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 50 units.
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