🔍 RecallPedia

Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body

Class I - Dangerous
🏥 Medical Devices Recalled: July 8, 2016 Carestream Health Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043
  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:
Carestream Health Inc
Reason for Recall:
A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body

Product Codes/Lot Numbers:

Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043

Distribution:

Distributed in: US, GA, IA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2217-2016

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