Events

Medicina Orange Enteral Feeding Pump (MD-OP900) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australasian Medical & Scientific 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-2015-RN-00125-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00125-1
  • 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
    Australasian medical& scientific ltd (amsl) is informing their customers that the safety and performance of these devices have not been properly evaluated and so the ce marking of the device is not valid.
  • 조치
    Australasian Medical & Scientific Limited (AMSL) is requesting the customers to inspect their stock for the affected devices and quarantine all units. AMSL will arrange for the affected stock to be recovered and a credit note issued. This action has been closed-out on 03/08/2016.

Device

Medicina Orange Enteral Feeding Pump (MD-OP900)
  • 모델명 / 제조번호(시리얼번호)
    Medicina Orange Enteral Feeding Pump (MD-OP900) All Batch NumbersOrder code: MD-OP900 ARTG No. 188940
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd