Events

Retiro De Equipo (Recall) de Essenta DR X-ray 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-2013-RN-01328-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-17
  • 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-2013-RN-01328-1
  • 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
    If during system installation, the screws holding the c-arm were mounted using thread locking compound (for example, loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
  • Acción
    Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site.

Device

Essenta DR X-ray System (Digital diagnostic X-Ray system)

Manufacturer

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