Events

Retiro De Equipo (Recall) de Olympus OER-AW Endoscope Reprocessor

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 Olympus Medical Systems Corporation.

¿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
    21126
  • Fecha de inicio del evento
    2017-02-21
  • 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: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Causa
    The operation manual for the oer-aw endoscope reprocessor has been updated to instruct users of non-detachable distal cover type duodenoscopes, such as the tjf-q180v duodenoscope, to follow the precleaning and manual cleaning as stated in the duodenoscope's reprocessing manual prior to setting them into the oer-aw.
  • Acción
    Instructions for use to be updated

Device

Olympus OER-AW Endoscope Reprocessor
  • Modelo / Serial
    Model: , Affected: Updated Version of Operation Manual: Relevant for models: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180V.
  • Manufacturer
    Olympus Medical Systems Corporation

Manufacturer

Olympus Medical Systems Corporation