Events

Retiro De Equipo (Recall) de DigitalDiagnost Release 3.1.x

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-00848-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-07
  • 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-00848-1
  • 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 healthcare has identified a firmware anomaly inside the detector (4343rc) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired x-ray images. a retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient.
  • Acción
    Philips is requesting that users: -Read the supplied notice. -Distribute the supplied notice to all users of the device in your facility. -Complete the response form and return it to Philips via fax/email within 3 business days as per the instructions in the customer letter. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented. Should users need to communicate with Philips with regard to this matter, reference Field Change Order 71200170.

Device

DigitalDiagnost Release 3.1.x

Manufacturer

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