Events

Retiro De Equipo (Recall) de Device Recall Etac Relax

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
    71707
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2381-2015
  • Fecha de inicio del evento
    2015-07-12
  • Fecha de publicación del evento
    2015-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138795
  • 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
    Adaptor, hygiene - Product Code ILS
  • Causa
    The recalling firm has received reports of a malfunction of the relax wall mounted shower seat where the wall bracket has cracked or broken.
  • Acción
    Etac sent an Urgent Field Safety Notice dated July 2015 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that there was no reason for an immediate stop of using Relax, however, as an intermediate precautionary action awaiting replacement, consumers were requested to be observant and inspect the Relax to see if there are visible signs of a crack. Customers with questions were advised to contact their Etac distributor or the Etac coordinator at 1-800-336-7684 or fax 1-704-882-0751.

Device

Device Recall Etac Relax
  • Modelo / Serial
    The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including FL, AZ, and CA.
  • Descripción del producto
    Etac Relax wall mounted shower seat || The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
  • 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