Events

Retiro De Equipo (Recall) de Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used for medical imaging acquisition)

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-00861-1
  • 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-00861-1
  • 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 due to potential incorrect display of mammographic measurements. the problem is that there is variability of how the estimated radiographic magnification factor (ermf) is provided in the dicom header data. when measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the hologic imager (different image) the measurements are not the same. use of this product may lead to additional imagining, such as mri and/or biopsy follow-up, before referring a patient to any surgical procedures. particularly if an mri or ultrasound is done the incorrect measurements would be identified as erroneous. this may result in a delay in diagnosis or treatment or patient misdiagnosis.
  • Acción
    A software upgrade will be implemented as a permanent correction. In the interim, users are advised not to use Merge PACS mammographic measurements until upgraded. The ability to create any measurements and annotations are controlled by together by a set of privileges which should be disabled until upgraded. This action has been closed-out on 22/02/2017.

Device

Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used f...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia