Events

Retiro De Equipo (Recall) de MAXIMOVE PATIENT LIFT

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
    123218
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-11-03
  • 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
    Arjohuntleigh has been made aware from internal testing and investigative activities that the conductive ink which is necessary for the activation of the handset function did not meet predetermined durability requirements. as part of our efforts to ensure customer satisfaction and product quality and performance arjohuntleigh has decided to perform a replacement of handset for the maxi move floor lifts affected by this issue which is not expected to affect the safety of the device but rather its durability.

Device

MAXIMOVE PATIENT LIFT
  • Modelo / Serial
    Model Catalog: KMC*** (Lot serial: >100 numbers contact mfg)
  • Descripción del producto
    ARJOHUNTLEIGH MAXI MOVE HANDSET
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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