Company:Edap Technomed Inc.
Date of Enforcement Report 11/1/2017
Class lI:
PRODUCT
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Recall Number Z-0049-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Edap Technomed Inc., Austin, TX on 8/14/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12
DISTRIBUTION
US Distribution to states of: NY, FL CA, NC, TX and NJ.
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