Events

Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Topcon Corporation 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
    18685
  • 사례 시작날짜
    2015-06-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    In certain usage environments, when the 3d oct-1 is used over a prolonged period of time, dust can penetrate into the optical system and adhere to the surface of the lens. this dust accumulates gradually over time and this can cause a whitish shadow artefact to occur in centre of the image and potentially create a blurry background., if this occurs, the reduced image quality is an obvious anomaly noticed during clinical assessment which cannot be mistaken for patient pathology.
  • 조치
    Product to be modified

Device

Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems
  • 모델명 / 제조번호(시리얼번호)
    Model: TOP-470109800, Affected: Serial number range: 105104 to 105701
  • Manufacturer
    Topcon Corporation

Manufacturer

Topcon Corporation