Events

Sirona Dac Universal Combination Steriliser 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sirona Dental Systems 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-00771-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00771-1
  • 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
    Dac universal mkiii units may have been repaired using spare parts intended for mkii units. there is the possibility of 12mm screws being used as a replacement for the original 16mm screws in the lid holder assembly. in the case, where the incorrect screws are fitted the lid could possibly become unmounted from the unit during its operation. there is a risk that people standing nearby could be harmed if hit by a released lid.
  • 조치
    Sirona is advising users to discontinue use of the affected machines until a service technician has inspected and corrected the machine, where required. Users are reminded to continue to manually clean and lubricate the instruments using T1 spray. This action has been closed out on 15 June 2017.

Device

Sirona Dac Universal Combination Steriliser
  • 모델명 / 제조번호(시리얼번호)
    Sirona Dac Universal Combination SteriliserSerial Number Range: 104000-199999, 202000-999999, B14000-B99999, B104000-B199999, B202000-B999999ARTG Number: 197032
  • Manufacturer
    Sirona Dental Systems Pty Ltd

Manufacturer

Sirona Dental Systems Pty Ltd