🔍 RecallPedia

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

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

What Should You Do?

  1. Check if you have this product:
    1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090, 337116, 337136, 345016, 345032, 345099, 345104.
  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:
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

Product Codes/Lot Numbers:

1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090, 337116, 337136, 345016, 345032, 345099, 345104.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2602-2025

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