Events

Retiro De Equipo (Recall) de INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2014-RN-00662-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-23
  • 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-2014-RN-00662-1
  • 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
    Intelerad medical systems inc. following internal testing, is providing additional information regarding the proper usage of the intelepacs software. this issue relates to the compression of images into jpeg 2000 (2c) format. in specific circumstances, when writing image data to storage that has filled up, the image data may become truncated.
  • Acción
    In order to correct this issue, a new software release will be installed on affected systems. Intelerad will run an audit on the entire PACS to identify all image data that may be truncated. For any affected studies, Intelerad will be able to restore a full fidelity image if required by the customers. This action has been closed-out on 29/01/2016.

Device

INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia