Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ablatherm(R) Integrated Imaging Recalled by Edap Technomed Inc. Due to The US FDA has requested the optional energy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edap Technomed Inc. directly.
Affected Products
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Quantity: 12 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 6 states: CA, FL, NJ, NY, NC, TX
About Edap Technomed Inc.
Edap Technomed Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report