Retiro De Equipo (Recall) de Intelerad InteleradPACS

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 Intelerad Medical Systems Incorporated.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
  • Causa
    Images successfully transmitted to intelepacs may not be available for reading in all studies. this failure can be detected if the client has image count verification protocols. this failure can also be detected if complete series are missing as the user will know to look for those missing series. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy, which is also highly detectable. however, under certain circumstances it can appear as if the study is complete with no user observable means to identify the failure. no patient incident has been reported to date.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: , Affected: Software versions: 4.7.1 R27 and up, 4.8.1 R20 and up, 4.9.1 R17 and up, 4.10.1 R9 and up, 4.11.1 R3 and up
  • Manufacturer