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Edap Technomed Inc. recalls Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high inte
Recalled November 1, 2017 · FDA recall Z-0049-2018 · Edap Technomed
Hazard
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. · FDA Class II
Units
12 units
Sold at
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Description
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.
Product
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Manufacturer(s)
Edap Technomed Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →