Events

Retiro De Equipo (Recall) de ALENTI LIFT HYGIENE CHAIR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ARJO CANADA 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
    107504
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-05-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    To further reduce the number of incidents associated with the alenti chair arjohuntleigh would like to re-iterate the important safety information. previous field safety correction actions reiterated the importance of following the instructions for use provided and included the introduction of a supplementary wall chart in the 2007 action. arjohuntleigh has revised the supplementary wall chart in april 2013. the changes include: 1. the correct instruction to not activate the alenti brake after the patient is removed from the bath tub. 2. the correct instruction to dry the patient inside the bath tub.

Device

ALENTI LIFT HYGIENE CHAIR
  • Modelo / Serial
    Model Catalog: CDB8153-01 (Lot serial: NA); Model Catalog: CDB8003-01 (Lot serial: NA); Model Catalog: CDB8053-01 (Lot serial: NA); Model Catalog: CDB8103-01 (Lot serial: NA)
  • Descripción del producto
    Alenti Lift & Hygiene Chair
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

ARJO CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC