Events

Retiro De Equipo (Recall) de Computer assisted hair harvesting system accessory

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 Restoration Robotics.

¿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
    66558
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0353-2014
  • Fecha de inicio del evento
    2013-10-13
  • Fecha de publicación del evento
    2013-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122603
  • 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
    Computer assisted hair harvesting system - Product Code ONA
  • Causa
    Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. discoloration due to insufficient cleaning of stainless steel pins during passivation process. the residue has been identified as a compound of iron and chlorine.
  • Acción
    Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760

Device

Computer assisted hair harvesting system accessory
  • Modelo / Serial
    Model number FP-45384
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
  • Descripción del producto
    Epsilon Skin Tensioner:Rx, Sterile || Sterilized using Gamma. Turns Red if sterilized using Gamma; || Product Usage: || Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
  • Manufacturer
    Restoration Robotics

Manufacturer

Restoration Robotics
  • Dirección del fabricante
    Restoration Robotics, 128 Bayview Drive, San Jose CA 95134
  • Empresa matriz del fabricante (2017)
    Restoration Robotics, Inc
  • Source
    USFDA