Events

Retiro De Equipo (Recall) de IntelePACS software versions from 4.5.1 to 4.11.1.

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-00705-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-04
  • 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-00705-1
  • 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
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred.The user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • Acción
    In order to correct this problem, Intelerad is: 1- providing concerned clients with a list of affected studies and possibly recover the missing images; 2- deploying a software update that includes both a fix and a mitigation for all clients potentially affected by the problem; and 3- periodically auditing all concerned client systems to find and report to the concerned client any new occurrences of this problem until the software update is in place.

Device

IntelePACS software versions from 4.5.1 to 4.11.1.
  • Modelo / Serial
    IntelePACS software versions from 4.5.1 to 4.11.1.Affected software version identifiers:· Identifier contains a “P” (for example PACS 4.5.1 P123)OR· Identifier contains an “R” but with a number below the following:- PACS-4-5-1-R70- PACS-4-6-1-R80- PACS-4-8-1-R40- PACS-4-9-1-R30- PACS-4-10-1-R30- PACS-4-11-1-R20
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia