Events

Retiro De Equipo (Recall) de Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014

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-2016-RN-00871-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-29
  • 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-00871-1
  • 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
    This recall has been initiated because studies that have qc, pde or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. use of this product may result in demographic changes to studies not being passed downstream to other pacs servers whether in-house or used for tele-radiology transfers.Not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis as the physician may not receive the required study. there have been no reports of injuries as a result of this issue.
  • Acción
    Emergo is advising users to use DICOM transfers rather than telmed transfers to receiving sites. If there is a valid failure, retrieve the study from archive and resend. It is recommended that logs are reviewed to ensure that all studies have been sent to receiving physicians. Emergo will be implementing a software correction as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture ar...
  • Modelo / Serial
    Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia