Events

Retiro De Equipo (Recall) de FemTouch delivery system

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 Lumenis Limited.

¿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
    75384
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0301-2017
  • Fecha de publicación del evento
    2016-10-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150176
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Causa
    The cleaning instructions provided in femtouch operator's manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
  • Acción
    On 9/25/16 consignees were notified via an Urgent - Field Safety Corrective Action letter with a FemTouch disassembly tool kit as well as FemTouch disassembly instructions. The instructions describe the simple disassembly process to be performed as part of the Pre-cleaning phase and the process for reassembling the device prior to re-use. It is recommended that customers clean and sterilize all of their handpieces according to the pre-cleaning disassembly process before each use. Consignees were asked to complete and return a verification form. Questions about the FSCA, should be directed to the Lumenis field correction administrator, Rafi Barel at Rafi.Barel@lumenis.com.

Device

FemTouch delivery system
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
  • Descripción del producto
    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) || Provide fractional treatments in gynecology.
  • Manufacturer
    Lumenis Limited

Manufacturer

Lumenis Limited
  • Dirección del fabricante
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Empresa matriz del fabricante (2017)
    Laguna Holdco Ltd
  • Source
    USFDA