Retiro De Equipo (Recall) de Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Arjo Australia Pty Ltd.

¿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
    RC-2018-RN-00123-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-28
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Arjo has received a limited number of complaints where it was noted there was a disconnection of the spreader bar from the quick connect scale.This occurence may result in users falling whilst the device is in use.
  • Acción
    Arjo will be in contact with affected users to arrange for devices to be upgraded

Device

  • Modelo / Serial
    Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.Part Number: 700-19490Serial Numbers range 300142013 - 300219867Part Number: 700-19485 Serial Numbers range 300146551 - 300220716ARTG Number: 276363(Arjo Australia - Scale, patient, sling)
  • Manufacturer

Manufacturer

  • Source
    DHTGA