STERRAD 100NX (Gas Plasma Steriliser) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2013-RN-01242-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-11-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The manufacturer, asp has determined that welds could loosen on the frame of sterrad 100nx sterilizers manufactured between october 2012 and june 2013. these welds are used to secure support rails to the top tray assembly for added rigidity. the failure of the broken weld could potentially cause the chassis to deflect concaving downward. this failure does not impact the sterrad 100nx sterilizer components performance.
  • 조치
    A JJM Field Service Engineer will install rivets and brackets to ensure the support rail brackets are firmly attached to the chassis to prevent possible separation.

Device

  • 모델명 / 제조번호(시리얼번호)
    STERRAD 100NX (Gas Plasma Steriliser)Product Number: 10104-002Affected Serial Numbers: 1042130065, 1042130028, 1042130024, 1042130067, 1042130002, 1042130063, 1042130064ARTG Number: 123603
  • Manufacturer

Manufacturer