🔍 RecallPedia

728333 Spectral CT 7500 -Computed Tomography X-ray system

Class I - Dangerous
🏥 Medical Devices Recalled: June 8, 2021 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option
  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:
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

728333 Spectral CT 7500 -Computed Tomography X-ray system

Product Codes/Lot Numbers:

Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2318-2021

Related Recalls