🔍 RecallPedia

AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

Class I - Dangerous
🏥 Medical Devices Recalled: February 10, 2020 Agfa N.V. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 00949, 1161
  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:
Agfa N.V.
Reason for Recall:
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

Product Codes/Lot Numbers:

Serial Numbers: 00949, 1161

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1502-2020

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