SmartPath to dStream for XR and 3.0T recall
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Why was SmartPath to dStream for XR and 3.0T recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
- Recalling firm
- Philips North America
- Quantity
- 294 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.
- Recall date
- August 6, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)