Events

A-dec 200 Dental Chair (examination chair) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 A-DEC Australia 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-2012-RN-01114-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01114-1
  • 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
    Preliminary analysis indicates that several lots of mounting bolts were subjected to plating conditions that may have contributed to hydrogen embrittlement, which in turn could cause mounting bolt failure. it was also determined that in addition to mounting bolts for the support centre that mounting bolts for the upper structure attachment to the chair base could also have been subjected to plating conditions that may have contributed to hydrogen embrittlement.This recall action was not notified to the tga before it was initiated by a-dec australia.
  • 조치
    The sponsor is advising users that the dealer will be replacing the four support centre bolts.

Device

A-dec 200 Dental Chair (examination chair)
  • 모델명 / 제조번호(시리얼번호)
    A-dec 200 Dental Chair (examination chair)All batches/serial numbers manufactured since March 2011ARTG Number: 118326
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA