FDAFDA · Alimentos y medicamentos·N.º oficial Z-2205-2025
Ingenia 1.5T S Model Number (REF): 781347;
Publicado el 6 de agosto de 2025 · Inicio del retiro: 30 de junio de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips North America
- Distribuidor
- 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.
- Lote
- Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81023, 81024, 81025, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81037, 81038, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81048, 81049, 81050, 81051, 81052, 81055, 81056, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81067, 81070, 81071, 81072, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81084, 81085, 81086, 81087, 81088, 81090, 81091, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81103, 81105, 81106, 81108, 81111, 81112, 81113, 81114, 81115, 81116, 81117, 81118, 81122, 81123, 81124, 81126, 81127, 81128, 81129, 81131, 81132, 81133, 81137, 81138, 81139, 81140, 81145, 81146, 81147, 81148, 81149, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81173, 81174, 81175, 81176, 81178, 81179, 81180, 81184, 81185;
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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