🔍 RecallPedia

Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue

Class I - Dangerous
🏥 Medical Devices Recalled: August 14, 2017 Edap Technomed Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
  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:
Edap Technomed Inc.
Reason for Recall:
The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue

Product Codes/Lot Numbers:

Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267

Distribution:

Distributed in: US, NY, FL, CA, NC, TX, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0049-2018