Events

Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2014-RN-00736-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00736-1
  • 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
    Haag streit has identified a potential issue with the slide-in adaptor plug for the perkins mkiii tonometer charger. an incident was reported to haag-streit where the use of the adaptor tripped a customer’s circuit breaker. upon investigation it was found the adaptor contained an electrical fault. this electrical fault has the potential to cause arcing within the adaptor, which poses a potential fire hazard. the risk when using the adaptor is most apparent if the adaptor is used in an un-fused circuit. the risk of harm and damage can be reduced if the unit is plugged into a conforming power outlet with a circuit breaker.
  • 조치
    Users are advised to isolate the affected Plug Adaptors from use. A DTA representative will contact users in regards to replacement of affected stock.

Device

Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer
  • 모델명 / 제조번호(시리얼번호)
    Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer Product Code: CC-5806004Serial Numbers: 274, 275, 276, 731, 732, 733, 453, 490, 452, 360ARTG Number: 151673
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd