Events

Retiro De Equipo (Recall) de APS EVOTECH Integrated Endoscope Disinfection System

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 Advanced Sterilization Products.

¿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
    15928
  • Fecha de inicio del evento
    2013-12-20
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer of evotech® endoscope cleaner and reprocessors (ecr) has discovered that the evotech® ecr may cancel cycles when reprocessing the pentax eg-3670urk flexible endoscope. the pentax eg-3670urk flexible endoscope has been qualified for use with the evotech® ecr, however it cannot currently be processed in the evotech® ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
  • Acción
    Software to be upgraded

Device

APS EVOTECH Integrated Endoscope Disinfection System

Manufacturer

Advanced Sterilization Products