Events

Retiro De Equipo (Recall) de GE Centricity PACS RA1000 Workstation

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Medical Systems Information Technologies.

¿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
    15225
  • Fecha de inicio del evento
    2013-08-20
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The manufacturer has become aware of several potential safety issues due to out of context and measurement issues associated with specific workflows with this device:, 1/ in centricity ris-ic, and a ris-driven integration, the "close" button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation,, 2/ interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation,, 3/ interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation,, 4/ centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag.
  • Acción
    Software to be upgraded

Device

GE Centricity PACS RA1000 Workstation

Manufacturer

GE Medical Systems Information Technologies