Events

Retiro De Equipo (Recall) de Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (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-00872-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-07
  • 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-00872-1
  • 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 action has been initiated because the cross reference lines a.K.A. cut lines or localiser lines may not display properly. this is due to math error when calculating the cut line position for studies with extremely high precision in the dicom tag image orientation patient (0020,0037) containing values of greater than 15 significant digits. the patient tag on affected images includes the value "e-16". when the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study. this may impact diagnosis when images are unavailable for viewing.
  • Acción
    Merge is working on correcting the issues and will inform customers once a fix is available. In the interim, users are advised that in order to view the study with the cross reference lines, it is recommended to view the study on another workstation of the modality device. Also, examine the image orientation patient tag to see if there are values with "e-16" included to see if a study in question could be affected. This action has been closed-out on 27/02/2017.

Device

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater...
  • Modelo / Serial
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia