🔍 RecallPedia

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Class I - Dangerous
🏥 Medical Devices Recalled: October 29, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;
  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:
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Product Codes/Lot Numbers:

1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0882-2026

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