🔍 RecallPedia

Sedecal SA Mobile Diagnost w DR x-ray system

Class I - Dangerous
🏥 Medical Devices Recalled: March 23, 2015 Sedecal USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    System Code 712001
  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:
Sedecal USA, Inc.
Reason for Recall:
Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Sedecal SA Mobile Diagnost w DR x-ray system

Product Codes/Lot Numbers:

System Code 712001

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1691-2016