Events

Retiro De Equipo (Recall) de Powered Wheelchairs Joystick

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Red Milawa Pty Ltd T/A Magic Mobility.

¿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-00497-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00497-1
  • 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
    Magic mobility has been notified of a component issue resulting in the direct actuator control switching, through the jack input socket, to not function correctly.This issue may cause either an incorrect switch/actuator operation or an inoperable external switch/actuator. at the time of dispatch from magic mobility, any wheelchairs fitted with this joystick did not require the use of the jack input socket. the wheelchairs performance is not compromised in its despatched state.However, if in the future, a client wishes to use the jack for a switch, then the jack may not work correctly. this issue would be detected immediately and therefore poses no safety risk.
  • Acción
    Magic Mobility has identified and quarantined all affected serial numbers. Those units currently with customers are identified and a replacement scheme for the affected component has been initiated. Magic Mobility will be contacting affected customers directly.

Device

Powered Wheelchairs Joystick
  • Modelo / Serial
    Powered WheelchairsJoystickPart Number: D51581 R-NET CJSM-L-SWSerial Numbers: BN18032803, BN18032873 and BN18032894ARTG Number: 118288
  • Manufacturer
    Red Milawa Pty Ltd T/A Magic Mobility

Manufacturer

Red Milawa Pty Ltd T/A Magic Mobility