Events

Retiro De Equipo (Recall) de Hologic Mini C-arm

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 Hologic Inc.

¿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
    14588
  • Fecha de inicio del evento
    2013-06-06
  • 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: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Causa
    Manufacturer has identified the following compliance issues:, 1.The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate., 2. the total cumulative irradiation time display is not accuarate., both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions., this non-compliance does not pose a health hazard, as the radiation exposure to a patient depends on power settings during the procedure. the system provides the user with accurate dose to the patient information by displaying air kerma and cumulative air kerma.
  • Acción
    Software to be upgraded

Device

Hologic Mini C-arm
  • Modelo / Serial
    Model: InSight and InSight 2, Affected:
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    NZMMDSA