🔍 RecallPedia

Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

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) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608; Serial Numbers: (1) 45010, 45023, 45028, 45029, 45032, 45033, 45034, 45037, 45040, 45041, 45043, 45045, 45046, 45048, 45049, 45053, 45066, 45070, 45072, 45076, 45087, 45090, 45091, 45092, 45093, 45102, 45105, 45108, 45115, 45116, 45119, 45127, 45136, 45138, 45140, 45144, 45147, 45154, 45156, 45157, 45162, 45168, 45181, 45184, 45189, 45191, 45194, 45205, 45222, 45227, 45231, 45243, 45244, 45245, 45246, 45250, 45252, 45263, 45272, 45277, 45278, 45289, 45290, 45296, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45362, 45374, 45379, 45414, (2) 45503, 45508, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45543, 45545, 45547, 45551, 45559, 45560, 45561, 45568, 45573, 45574, 45578, 45580, 45589, 45594, 62011, 62023, 62024, 62026, 62030, 62031, 62033, 62035, 62038, 62040, 62041, 62047, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62065, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62088, 62092, 62134, 62136, 62137, 62152, 62153, 62159, 62178, 62181, 62182, 62191, 62197, 62198, 62199, 62212, (3) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28568, 28569, 28572, 28575, 28581;
  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 X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

Product Codes/Lot Numbers:

Model Numbers: (1) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608; Serial Numbers: (1) 45010, 45023, 45028, 45029, 45032, 45033, 45034, 45037, 45040, 45041, 45043, 45045, 45046, 45048, 45049, 45053, 45066, 45070, 45072, 45076, 45087, 45090, 45091, 45092, 45093, 45102, 45105, 45108, 45115, 45116, 45119, 45127, 45136, 45138, 45140, 45144, 45147, 45154, 45156, 45157, 45162, 45168, 45181, 45184, 45189, 45191, 45194, 45205, 45222, 45227, 45231, 45243, 45244, 45245, 45246, 45250, 45252, 45263, 45272, 45277, 45278, 45289, 45290, 45296, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45362, 45374, 45379, 45414, (2) 45503, 45508, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45543, 45545, 45547, 45551, 45559, 45560, 45561, 45568, 45573, 45574, 45578, 45580, 45589, 45594, 62011, 62023, 62024, 62026, 62030, 62031, 62033, 62035, 62038, 62040, 62041, 62047, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62065, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62088, 62092, 62134, 62136, 62137, 62152, 62153, 62159, 62178, 62181, 62182, 62191, 62197, 62198, 62199, 62212, (3) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28568, 28569, 28572, 28575, 28581;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1803-2025

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