Events

Retiro De Equipo (Recall) de Ablatherm Integrated Imaging device

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Edap Technomed Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78092
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0049-2018
  • Fecha de inicio del evento
    2017-08-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158643
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    High intensity ultrasound system for prostate tissue ablation - Product Code PLP
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: NY, FL CA, NC, TX and NJ.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Edap Technomed Inc., 5321 Industrial Oaks Blvd Ste 110, Austin TX 78735-8823
  • Empresa matriz del fabricante (2017)
    EDAP TMS SA
  • Source
    USFDA