Events

Retiro De Equipo (Recall) de IntelePACS InteleViewer software version 4.11.1 P144 (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-2016-RN-00199-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-25
  • 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-00199-1
  • 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
    Since the introduction of a fix to the measurements algorithm (bz55214), inteleviewer now uses the ratio of the distance from the source to patient over distance from source to detector to compute a scaling factor to apply to measurements when the estimated radiographic magnification factor (dicom (0018,1114)) is not present. that scaling should only be applied when dealing with a projection radiography modality (cr, dx, mg, px, rf, or xa), however, it ended up being applied to other modalities, such as ct, generating erroneous measurements.This software defect could lead radiologists to base their diagnosis/report on wrong anatomical measurements. no patient incidents have been reported at this time.
  • Acción
    Emergo is advising users to ensure that they uninstall the affected software version from their workstations and install an alternative version of lnteleViewer (e.g. IV 4-11-1 P143 or IV 4-11-1 P145). Also, users are advised to review the studies that were done with lnteleViewer 4-11-1 Pl44 and determine appropriate follow-up with patients. Users will be provided with the list of potentially affected studies.

Device

IntelePACS InteleViewer software version 4.11.1 P144 (Radiology picture archiving and communicati...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia