Events

Retiro De Equipo (Recall) de Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carestream Health Australia Pty 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-2013-RN-01022-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-03
  • 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-2013-RN-01022-1
  • 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
    Carestream health australia has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios.This problem occurs infrequently and only when all of the following conditions are met:1) the version installed is v11.3.2 or v11.3.2.4 or v11.42) the exam type is from multi-slice modalities3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images.4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Acción
    Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol.

Device

Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4
  • Modelo / Serial
    Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4Catalogue number & description:1308519 VIRT PWR Reading Basic SW Workgroup1530633 VIRT PWR Reading Basic SW 8 Pack1467067 Virtual Reading Basic SW Workgroup1405794 Virtual Reading Basic SW 8 Pack8171837 Virtual Enterprise SW StandaloneARTG Number: 135310
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd