BEUDAMED
    FDA Enforcement Class II Terminated

    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue

    Recall: Z-0049-2018 · Reported November 1, 2017

    Enforcement

    Recall Number
    Z-0049-2018
    Event ID
    78092
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edap Technomed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 1, 2017
    Initiation Date
    August 14, 2017
    Classification Date
    October 26, 2017
    Termination Date
    August 4, 2020
    Address
    5321 Industrial Oaks Blvd Ste 110, N/A, Austin, TX, 78735-8823, United States

    Description

    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue

    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.

    Code Info

    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267

    Distribution

    US Distribution to states of: NY, FL CA, NC, TX and NJ.

    Quantity

    12 units