🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: June 30, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2216-2025

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