Retiro De Equipo (Recall) de Device Recall Eleganza 3 Hospital Bed

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 Linet Americas 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
    58785
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2411-2011
  • Fecha de inicio del evento
    2011-05-02
  • Fecha de publicación del evento
    2011-06-03
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Bed, hydraulic, adjustable hospital - Product Code FNK
  • Causa
    Linet has been made aware that there has been breakage of the mobi-lift handle on a few beds which may cause failure during patient assist use.
  • Acción
    The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design. If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446.

Device

  • Modelo / Serial
    Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accesory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides), Serial Numbers: 20100043034 to 20100043045
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.
  • Descripción del producto
    Eleganza 3 Hospital Bed || Intended use: AC Powered adjustable Hospital Bed
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Linet Americas Inc, 10430 Harris Oak Blvd, Ste A, Charlotte NC 28269-7511
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA