🔍 RecallPedia

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Class I - Dangerous
🏥 Medical Devices Recalled: April 13, 2021 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 100100, 100434
  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:
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Product Codes/Lot Numbers:

Serial Numbers: 100100, 100434

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1774-2021

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