🔍 RecallPedia

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

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) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258, 46263, 46265, 46268, 46269, 46270, 46281, 46282, 46286, 46289, 46292, 46297, 46304, 46307, 46310, 46311, 46315, 46316, 46317, 46324, 46325, 46326, 46331, 46338, 46348, 46352, 46353, 46354, 46362, 46363, 46367, 46368, 46375, 46376, 46383, 46384, 46387, 46390, 46394, 61010, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64039, 64045, 64046, (4) 26001, 26002, 26003, 26004, 26005, 26006, 26007, 26008, 26010, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26020, 26021, 26022, 26023, 26024, 26026, 26027, 26029, 26030, 26031, 26032, 26034, 26035, 26036, 26037, 26038, 26039, 26040, 26041, 26042, 26043, 26045, 26047, 26049, 26051, 26052, 26053, 26054, 26056, 26058, 26059, 26060, 26061, 26062, 26063, 26064, 26065, 26066, 26067, 26068, 26069, 26073, 26075, 26076, 26082;
  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 Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Product Codes/Lot Numbers:

Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258, 46263, 46265, 46268, 46269, 46270, 46281, 46282, 46286, 46289, 46292, 46297, 46304, 46307, 46310, 46311, 46315, 46316, 46317, 46324, 46325, 46326, 46331, 46338, 46348, 46352, 46353, 46354, 46362, 46363, 46367, 46368, 46375, 46376, 46383, 46384, 46387, 46390, 46394, 61010, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64039, 64045, 64046, (4) 26001, 26002, 26003, 26004, 26005, 26006, 26007, 26008, 26010, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26020, 26021, 26022, 26023, 26024, 26026, 26027, 26029, 26030, 26031, 26032, 26034, 26035, 26036, 26037, 26038, 26039, 26040, 26041, 26042, 26043, 26045, 26047, 26049, 26051, 26052, 26053, 26054, 26056, 26058, 26059, 26060, 26061, 26062, 26063, 26064, 26065, 26066, 26067, 26068, 26069, 26073, 26075, 26076, 26082;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2210-2025

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