Events

Retiro De Equipo (Recall) de Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging 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-2017-RN-01217-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-27
  • 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-2017-RN-01217-1
  • 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
    Philips has recently performed evaluations of the mobile detector holder and has identified a potential issue that may affect the performance of the equipment under certain conditions. if the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. this may happen when the detector is rotated clockwise from landscape to portrait position.The wireless portable detector (wpd) 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° clockwise from landscape.
  • Acción
    1. Users should read the notice and check the lock mechanism of the Mobile Detector Holder. The lock mechanism can be moved without pressing the actuator, the holder should not be rotated clockwise. a. Distribute the notice to all users of the device and complete the supplied response form and return it to. Philips via fax/email within three (3) business days. b. Philips will contact users to schedule a correction to the affected units.

Device

Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of...
  • Modelo / Serial
    Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging system)ARTG Number: 293924
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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