Events

Recall of Ablatherm Integrated Imaging device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edap Technomed Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78092
  • Event Risk Class
    Class 2
  • Event Number
    Z-0049-2018
  • Event Initiated Date
    2017-08-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158643
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    High intensity ultrasound system for prostate tissue ablation - Product Code PLP
  • 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 service@edap-usa.com at any time, 24 hours a day, 7 days a week.

Device

Ablatherm Integrated Imaging device
  • Model / Serial
    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: NY, FL CA, NC, TX and NJ.
  • Product Description
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation || Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
  • Manufacturer
    Edap Technomed Inc.

Manufacturer

Edap Technomed Inc.
  • Manufacturer Address
    Edap Technomed Inc., 5321 Industrial Oaks Blvd Ste 110, Austin TX 78735-8823
  • Manufacturer Parent Company (2017)
    EDAP TMS SA
  • Source
    USFDA