🔍 RecallPedia

Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

Class I - Dangerous
🏥 Medical Devices Recalled: May 16, 2013 U-systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Serial numbers: H1280099, H1180094, B1380105
  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:
U-systems Inc
Reason for Recall:
Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

Product Codes/Lot Numbers:

Serial numbers: H1280099, H1180094, B1380105

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1587-2013