Nov

2017

Ablatherm(R) Integrated Imaging Cl II

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.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Ablatherm(R) Integrated Imaging Cl II

Amy Sellers

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