IQon Spectral CT Model # 728332, computed tomography x-ray system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    System Serial Number 860004 through 860043, 860046 through 860127, 890002
  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 Medical Systems (Cleveland) Inc
Reason for Recall:
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

IQon Spectral CT Model # 728332, computed tomography x-ray system

Product Codes/Lot Numbers:

System Serial Number 860004 through 860043, 860046 through 860127, 890002

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2192-2019

Related Recalls

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

Aug 5, 2025 Other Medical Devices Nationwide View Details →