Events

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
    Recall
  • ID del evento
    18974
  • Fecha de inicio del evento
    2015-08-20
  • 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: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
  • Causa
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred., the user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • Acción
    Software to be upgraded

Device

Intelerad InteleradPACS
  • Modelo / Serial
    Model: , Affected: Software version contains a "P" (eg PACS 4.5.1 P123) or contains an "R" with the following: PACS-4-5-1-R70, PACS-4-6-1-R80, PACS-4-8-1-R40, PACS-4-9-1-R30, PACS-4-10-1-R30, PACS-4-11-1-R20, Software version: Versions 4.5.1 to 4.11.1
  • Manufacturer
    Intelerad Medical Systems Incorporated

Manufacturer

Intelerad Medical Systems Incorporated