Events

Retiro De Equipo (Recall) de Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)

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 Topcon Medical Laser Systems 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
    20631
  • Fecha de inicio del evento
    2016-10-17
  • 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: Optimed NZ Ltd, Unit 1, 3 Northside Drive, Whenuapai, Auckland 0814
  • Causa
    An anomaly has been discovered with titration, only when the epm software feauture is turrned on during the titration process., this event may occur if the user turns on epm, turns off the landmark (lm) function (with any epm supported pattern) and then enters titration mode. in either single or multiple spot titration patterns, the power output upon pressing the footswitch is the same as the epm power. the epm power is a percentage of the power selected in the epm control. the user would expect the power output during titration to be equal to 100% of the selected power level and may increase the power level during the titration process. when the expected tissue response is not observed, the power level resulting from titration will produce an over-power treatment when the user subsequently treats with the titration turned off.
  • Acción
    Software to be upgraded

Device

Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)
  • Modelo / Serial
    Model: , Affected: , Software version: 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2) and 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2)
  • Manufacturer
    Topcon Medical Laser Systems Inc

Manufacturer

Topcon Medical Laser Systems Inc