Reported Nov 1, 2017 · Terminated
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high…
Edap Technomed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edap Technomed Inc. · 5321 Industrial Oaks Blvd Ste 110 · Austin, TX · 78735-8823
Is this the product you have?
- Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
- Lot codes and dates
- Serial Numbers
AB127rAB206rAB220rAB254rAB200rAB214rAB223rAB266AB204rAB217rAB224rAB267
- Serial Numbers
- Amount recalled
- 12 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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