Events

Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtel 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-01014-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01014-1
  • 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
    The manufacturer, magstim has identified a manufacturing non-conformity on a single 9784-00, magstim 90mm high power coil. the nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. the failure mode would be such that a loud bang would be produced and the coil would cease to function. there could also be damage to the stimulator to which the coil was connected.
  • 조치
    Medtel is requesting users to stop using the coils. Product can be returned to Medtel for replacement with unaffected stock.

Device

Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cor...
  • 모델명 / 제조번호(시리얼번호)
    Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)Part Number: 9784-00Serial Numbers: 2687, 2676ARTG Number: 136823
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA