Events

Retiro De Equipo (Recall) de IntelePACS(Image management 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-2015-RN-00404-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-15
  • 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-2015-RN-00404-1
  • 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
    Images successfully transmitted to intelepacs may not be available for reading in all studies, and the reader could be unaware of missing images.. this failure can be detected if the client has image count verification protocols. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy.This issue can arises in two scenarios:1. for the three clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to forward all received images to the permanent storage servers and no record of these images persist in the main archive. 2. for the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure for the device to properly replicate and register images when transferring them to another server.
  • Acción
    For the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the Client Specific Release process (completed as of 2015-04-23) to avoid the possibility of data loss. For the remaining clients, the normal Full Release Update (FRU) will be expedited. This action has been closed-out on 5/08/2016.

Device

IntelePACS(Image management system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia