Events

Rappel de Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Topcon Medical Laser Systems Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20631
  • Date de mise en oeuvre de l'événement
    2016-10-17
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Optimed NZ Ltd, Unit 1, 3 Northside Drive, Whenuapai, Auckland 0814
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)
  • Modèle / numéro de série
    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