Events

Allersearch Economist Forte Nebuliser (non heated nebuliser) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ebos Group Pty Limited 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-2012-RN-00764-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00764-3
  • 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
    It is recongnised that there is an issue with the economist forte and the fit to the unit with the supplied power cord accessory. in some cases, the power cord moulding is too large to fit into the unit. it is necessary to state that there is no safety issue with the unit, other than the possibility of the device not working due to lack of power supply.
  • 조치
    The sponsor is asking pharmacies to return all affected stock to their wholesaler. The sponsor is asking all wholesalers to quarantine affected stock for return.

Device

Allersearch Economist Forte Nebuliser (non heated nebuliser)
  • 모델명 / 제조번호(시리얼번호)
    Allersearch Economist Forte Nebuliser (non heated nebuliser)Catalogue Number: AE650-040Batch Numbers: 11AD12 and 11AD12AARTG Number: 98386
  • Manufacturer
    Ebos Group Pty Limited

Manufacturer

Ebos Group Pty Limited