Events

ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hologic Australia 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-2016-RN-01040-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01040-1
  • 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
    Hologic have identified that the lid of the atec canister may have cracks that are related to lost/no vacuum during an atec biopsy procedure.This issue can be discovered during the inspection of the canister during setup or via a system vacuum error when testing the eviva or atec biopsy needle. from customer complaints received to date there has not been any patient harm or other safety issue. however, the issue may prevent the system from enabling a procedure to continue.
  • 조치
    Hologic is advising users to inspect stocks and quarantine all affected units. Hologic will arrange for affected stock to be recovered and replacement stock, or a credit note, to be issued.

Device

ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)
  • 모델명 / 제조번호(시리얼번호)
    ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)Lot Number: 20150013ARTG Number: 215794
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd