Events

V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 January 2014 and 2 May 2016 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-2016-RN-00803-1
  • 사례 위험등급
    Class III
  • 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-00803-1
  • 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
    Steris has identified that v-pro 1, v-pro 1 plus, and v-pro max sterilisers manufactured after 1 january 2014 may not display the correct date as of 29 february 2016. while the v-pro units display an incorrect date, the steriliser functions and cycle operations continue to operate properly. if users do not manually change the system date of the v-pro unit, the unit’s display and cycle printout will contain an incorrect date.
  • 조치
    Device Technologies is advising users that a service technician will be upgrading all affected systems. Users are advised that the system date can be amended using the instructions found in the Operator's Manual. The system can continue to be used as normal until corrected. This action has been closed-out on 11/05/2017.

Device

V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 Jan...
  • 모델명 / 제조번호(시리얼번호)
    V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation SystemsManufactured between 2 January 2014 and 2 May 2016ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd