Events

Retiro De Equipo (Recall) de SONY LMD-1951MD MONITORS

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

¿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-2015-RN-00032-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-16
  • 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-2015-RN-00032-1
  • 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
    In some situations, a lmd-1951md medical monitor has either not turned on or has lost the image during clinical use. sony's investigation indicates that the issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. this problem is caused by a non-conformity in the circuit board resulting in a short circuit with over-current and damage to the circuitry and concomitant loss of image. the failure does not occur when an ac adapter (ac-110md) is used with the monitor.
  • Acción
    Sony is replacing the power board of all affected units. In the interim, end users are advised to only use the AC adapter to avoid the issue occurring. This action has been closed-out on 18/07/2016.

Device

SONY LMD-1951MD MONITORS

Manufacturer

Sony Australia Limited
  • Empresa matriz del fabricante (2017)
    Sony Corp.
  • Source
    DHTGA