Events

LumaDent Light Battery Charger 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carl Zeiss 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-2016-RN-00746-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00746-1
  • 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
    Carl zeiss pty ltd, following advice from lumadent is replacing the battery charger of the lumadent light. this applies to all charger model numbers, except model number sw-084120. model number sw-084120, which is the only correct model for all lumadent batteries bp500 (v3.1, v3.2 and v3.3), is not affected by this recall. the affected battery chargers have not been demonstrated to comply with australian and new zealand electrical safety standards thus may have the potential to overcharge the batteries causing them to overheat and catch fire. there have been no reports of injuries as a result of this issue.
  • 조치
    Carl Zeiss are advising users to inspect all battery chargers and quarantine any batteries which are not model number SW-084120. Carl Zeiss will replace any affected stock. This action has been closed-out on 02/03/2017.

Device

LumaDent Light Battery Charger
  • 모델명 / 제조번호(시리얼번호)
    LumaDent Light Battery Charger All model numbers affected EXCEPT SW-084120ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd