Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
FDA Recall #Z-2207-2025 — Class II — June 30, 2025
Product Description
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Reason for Recall
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.
Recalling Firm
Philips North America — Cambridge, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
350 units
Distribution
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.
Code Information
Model Numbers (REF): (1) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000, 78003, 78004, 78005, 78007, 78008, 78009, 78010, 78011, 78012, 78013, 78014, 78015, 78016, 78017, 78018, 78019, 78021, 78022, 78023, 78025, 78026, 78027, 78028, 78029, 78030, 78031, 78032, 78033, 78034, 78035, 78036, 78038, 78039, 78040, 78042, 78043, 78044, 78045, 78046, 78047, 78048, 78049, 78050, 78051, 78053, 78058, 78059, 78060, 78062, 78063, 78064, 78065, 78066, 78067, 78068, 78070, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78081, 78082, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78095, 78096, 78097, 78098, 78099, 78100, 78101, 78102, 78103, 78104, 78106, 78107, 78109, 78110, 78111, 78112, 78113, 78114, 78115, 78117, 78118, 78120, 78121, 78122, 78123, 78126, 78127, 78128, 78129, 78132, 78133, 78135, 78137, 78138, 78139, 78140, 78141, 78142, 78145, 78147, 78148, 78149, 78150, 78151, 78154, 78155, 78156, 78157, 78158, 78161, 78162, 78164, 78166, 78167, 78170, 78171, 78172, 78173, 78175, 78180, 78181, 78182, 78183, 78186, 78187, 78188, 78189, 78190, 78193, 78194, 78195, 78196, 78197, 78198, 78199, 78201, 78202, 78203, 78205, 78206, 78207, 78208, 78209, 78210, 78212, 78213, 78214, 78215, 78216, 78217, 78218, 78219, 78221, 78222, 78223, 78224, 78225, 78227, 78229, 78232, 78233, 78234, 78235, 78238, 78239, 78240, 78241, 78242, 78243, 78244, 78247, 78249, 78250, 78251, 78252, 78253, 78254, 78255, 78256, 78257, 78259, 78260, 78261, 78262, 78263, 78264, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78277, 78279, 78280, 78281, 78282, 78283, 78284, 78286, 78287, 78288, 78289, 78290, 78291, 78292, 78293, 78294, 78295, 78296, 78297, 78298, 78299, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78324, 78326, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78336, 78337, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 2180210, (2) 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78532, 78533, 78535, 78536, 78537, 78538, 78539, 78540, 78541, 78542, 78543, 78544, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78552, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78566, 78567, 78568, 78570, 78573;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.