🔍 RecallPedia

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Class I - Dangerous
🏥 Medical Devices Recalled: June 30, 2021 GE Healthcare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
  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:
GE Healthcare, LLC
Reason for Recall:
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Product Codes/Lot Numbers:

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0242-2022

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