Z-2216-2025 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
August 6, 2025
Initiation Date
June 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
294 units

Product Description

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

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.

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.

Code Information

Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; UDI-DI: (1) 00884838095083, (2) 00884838098909, (3) 00884838105805; Serial Numbers: (1) 17006, 17172, 17204, 17206, 17212, 17215, 17222, 17237, 17239, 17240, 17242, 17245, 17246, 17247, 17250, 17260, 17264, 17265, 17266, 17268, 17269, 17274, 17283, 17284, 17286, 17290, 17292, 17299, 17302, 17308, 17309, 17313, 17321, 17326, 17339, 17342, 17344, 17352, 17353, 17356, 17357, 17360, 17366, 17367, 17369, 17375, 17378, 17386, 17388, 17389, 17398, 17399, 17406, 17415, 17416, 17425, 17428, 17429, 17434, 17436, 17440, 17447, 17459, 17464, 17466, 17468, 17473, 17490, 17491, 17493, 17495, 17499, 17508, 17509, 17514, 17516, 17517, 17524, 17533, 17536, 17544, 17546, 17550, 17556, 17559, 17564, 17565, 17569, 17570, 17572, 17580, 17589, 17590, 17594, 17615, 23002, 23026, 23030, 23033, 23034, 23036, 24006, 24012, 24013, 24018, 24020, 24022, 24023, 24025, 24036, 24047, 24055, 24058, 24075, 24076, 24087, 24090, 24095, 24098, 24108, 24109, 24110, 24111, 24117, 24124, 24133, 24134, 24143, 24145, 34032, 34036, 34037, 34058, 34060, 34067, 34076, 34080, 34083, 34090, 34096, 34107, 34111, 34142, 34145, 34152, 34154, 34211, 34221, 34223, 34233, 34236, 34246, 34249, 34250, 34261, 34292, 35027, 35031, 35032, 35040, 35043, 35044, 35046, 35047, 35048, 35052, 35053, 35056, 35060, 35073, 35078, 35087, 38001, 38004, 38005, 38006, 38013, 38015, 38020, 38023, 38026, 38032, 38037, 38038, 38040, 38041, 38062, 38063, 38065, 38071, 38076, 38084, 38089, 38102, 38109, 38111, 38113, 38116, 38120, 38126, 38131, 38134, 38135, 38138, 38161, 38168, 38184, 38192, 38198, 38199, 38202, 38214, 38217, 38224, 38225, 38235, 38259, 38263, 38300, 38317, 38356, 38366, 74011, (2) 17238, 17252, 17258, 17271, 17307, 17346, 17372, 17376, 17439, 17449, 17455, 17461, 17470, 17504, 17521, 17560, 24021, 24039, 24052, 24077, 24093, 24146, 34056, 34059, 34072, 34110, 34117, 34127, 34128, 34129, 34130, 34131, 34143, 34153, 34172, 34202, 34212, 34262, 34304, 35041, 35045, 35059, 35071, 38010, 38011, 38042, 38049, 38066, 38070, 38075, 38082, 38094, 38105, 38106, 38117, 38142, 38166, 38197, 38219, 38222, 38230, 38234, 38281, 38290, 38310, 38311, 38354, 74036, 74040, (3) 34055, 38195;