🔍 RecallPedia

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

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) 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;
  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:

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Product Codes/Lot Numbers:

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;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2207-2025

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