🔍 RecallPedia

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

Class I - Dangerous
🏥 Medical Devices Recalled: May 13, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045;
  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 Llc
Reason for Recall:
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

Product Codes/Lot Numbers:

Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1802-2025

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