Events

Microcatheter SONIC 1.5F 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getz Healthcare Pty 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-00618-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00618-1
  • 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
    Getz healthcare has been advised by their supplie, balt extrusion, that the manufacture, marketing, distribution, export and use of the microcatheter sonic 1.5f will be temporarily suspended. modifications to sonic 1.5f have been filed with the notified body in europe but the device has been put on the market prior approval. (the manufacturer is awaiting final clearance from the notified body before resupply).
  • 조치
    Getz Healthcare is advising users to inspect their stock and quarantine affected units. Users will be contacted to arrange for the return of their affected units for a credit note or replacement stock to be issued.

Device

Microcatheter SONIC 1.5F
  • 모델명 / 제조번호(시리얼번호)
    Microcatheter SONIC 1.5FProduct Code: SONIC1.5F25Lot Number: 00268901ARTG Number: 155392
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd