Events

Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. (Light Source for endoscopic procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Vision Sciences 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-00930-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00930-1
  • 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
    Vision-sciences received a limited number of reports relating to over-heating and possible burning of the lithium-ion batteries being charged with the vision-sciences battery charger. as a precautionary measure vision-science has initiated a recall action, to retrieve all battery charges and dispose of the rechargeable batteries. endoscopes or light sources are not affected by this recall. ashmed pty ltd is the current sponsor and distributor for the vision sciences inc range of endoscopes and accessories in australia and new zealand.
  • 조치
    AshMed Pty Ltd is requesting their customer to immediately remove Vanson V-95 Battery Charger from use and mail the affected charger/device to AshMed Pty Ltd, and dispose of rechargeable batteries as per the local regulations. AshMed Pty Ltd and Vision Sciences Inc will supply replacement disposable batteries for the BLS-1000 unit until a permanent replacement that will meet appropriate standards of quality and safety is found.

Device

Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied wit...
  • 모델명 / 제조번호(시리얼번호)
    Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. (Light Source for endoscopic procedures)Catalogue Numbers:BLS-1000 kit (battery & charger) - 07-3053-AUSCharger - 07-3058-AUSLithium-Ion Batteries - 07-3059ARTG Number: 137738
  • Manufacturer
    Vision Sciences Australia Pty Ltd

Manufacturer

Vision Sciences Australia Pty Ltd
  • Source
    DHTGA