Events

Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Topcon Medical Laser Systems Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20631
  • 사례 시작날짜
    2016-10-17
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: Optimed NZ Ltd, Unit 1, 3 Northside Drive, Whenuapai, Auckland 0814
  • 원인
    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.
  • 조치
    Software to be upgraded

Device

Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)
  • 모델명 / 제조번호(시리얼번호)
    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