Events

Pentax Ultrasound Video Bronchoscope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pentax Medical Pte Ltd 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
    RC-2017-RN-00908-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00908-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Pentax medical has become aware of an error in the description of the instructions for use (ifu) for a specific model of pentax ultrasound video bronchoscope relating to the reprocessing of scopes. following the instructions in the erroneous ifu may result in ineffective reprocessing which may pose a risk of contamination and/or anaphylactic shock.
  • 조치
    Pentax Medical is requesting customers ensure that all potential users in affected facilities are made aware of this recall action and are provided with the new Instructions For Use (IFU) supplied with the Customer Letter.

Device

Pentax Ultrasound Video Bronchoscope
  • 모델명 / 제조번호(시리얼번호)
    Pentax Ultrasound Video BronchoscopeModel Number: EB-1970UKAll Serial NumbersARTG Number: 234953
  • Manufacturer
    Pentax Medical Pte Ltd

Manufacturer

Pentax Medical Pte Ltd
  • Source
    DHTGA