Events

Retiro De Equipo (Recall) de iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128

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-2016-RN-01444-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-11-08
  • 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-2016-RN-01444-1
  • 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
    An incorrect current rating label has been applied to the rear side of the imr (single computer) host cabinet (4598-004-44981).The non-conforming label states the current rating as 4.8a (instead of 2.4a), as defined in the host rack imr specifications. the correct label on the host imr rack should have electrical rating values of: 230v — 2.4a, 50/60 hz.
  • Acción
    Philips Healthcare is notifying the affected users of those issues via this letter. A Philips Field Service Engineer will contact those users to schedule the Rack/Cabinet label re-work on-site. Reference Field Change Order (FCO) 72800667. This action has been closed-out on 23/06/2017.

Device

iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128
  • Modelo / Serial
    iMR Cabinet label of Brilliance iCT, Ingenuity CT, Ingenuity Core 128Part Number: 459800444981ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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