Ingenia 1.5T S Model Number (REF): 781347;

Reason: 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.

Code information: 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;

Distribution pattern: 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.