Events

Retiro De Equipo (Recall) de Etac Ono, Avant, and Salsa Walkers

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 Etac Supply Center Ab.

¿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
    61463
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2014-2012
  • Fecha de inicio del evento
    2012-04-06
  • Fecha de publicación del evento
    2012-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108163
  • 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
    Walker, mechanical - Product Code ITJ
  • Causa
    The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. one death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. among the walkers distributed worldwide, etac¿ has received a total of 49 reports from europe and japan of wheels falling.
  • Acción
    Etac sent an "URGENT DEVICE RECALL " letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue selling and distributing the affected product. A Reply Postcard was enclosed for customers to complete and return. Contact the firm at 847-277-7705 for questions regarding this recall.

Device

Etac Ono, Avant, and Salsa Walkers
  • Modelo / Serial
    Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand.
  • Descripción del producto
    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. || These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • Dirección del fabricante
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • Empresa matriz del fabricante (2017)
    Nordstjernan Ab
  • Source
    USFDA