BEUDAMED
    FDA Recall 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 · Initiated August 14, 2017

    Recall

    Recall Number
    Z-0049-2018
    Event Number
    78092
    Firm
    Edap Technomed Inc.
    FEI Number
    1287394
    Product Code
    PLP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 14, 2017
    Terminated
    August 4, 2020
    Address
    5321 Industrial Oaks Blvd, Ste 110, Austin, TX, 78735-8823

    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.

    Action

    The firm, EDAP TMS, company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an " URGENT FIELD SAFETY NOTICE" letter dated 8/22/2017 delivered by email on 08/29/2016. The letter described the product, problem and actions to be taken. The customers were instructed as follows: do not use the "medium" or "low" energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols "02-medium" and "03-low". If you have any questions regarding this notification, or experience any issues with your device, please contact EDAP TMS Customer Care Center at (512) 852-9685 or via email at [email protected] at any time, 24 hours a day, 7 days a week.

    Distribution

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

    Quantity

    12 units