Events

Retiro De Equipo (Recall) de Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2012-RN-01024-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-10-10
  • 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-2012-RN-01024-1
  • 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
    The wireless portable detector is fixed in the mobile detector holder via a lock mechanism. the 4 countersunk screws, that are used to attach the lock, mechanism, can become loose. if this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 degrees clockwise.
  • Acción
    The user should control the lock mechanism of the Mobile Detector Holder. In case the lock mechanism can be moved without pressing the actuator, the holder should not be rotated Clockwise. Philips Healthcare will secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (e.g. LOCTITE 243).

Device

Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System).
  • Modelo / Serial
    Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System). Models: Single Detector, Dual Detector, Release 3System codes: 712020, 712022 & 712025ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA