Events

da Vinci Xi Surgical System P6b Software 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-2017-RN-01543-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-01-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01543-1
  • 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
    Device technologies has learned from the manufacturer, intuitive surgical, that the updated da vinci xi surgical system user manual and the updated da vinci xi instrument and accessory user manual were not provided when the system upgrade was performed. the user manuals will be forwarded to affected customers.
  • 조치
    1. Device Technologies Australia will forward the updated manuals to affected customers. Once the updated System User Manual and the updated Instruments & Accessories User Manual have been received, disregard the previous versions of the system User Manual and the Instruments & Accessories User Manual. 2. Ensure all relevant personnel at your facility are fully informed of this notice, including medical staff who perform da Vinci® XiTM Surgery procedures. 3. Complete and return the supplied Reply Form to acknowledge receipt of this notice. 4. Retain a copy of this letter and the acknowledgement form within the updated System User Manual and the updated Instruments & Accessories User Manual of the da Vinci® XiTM System.

Device

da Vinci Xi Surgical System P6b Software

Manufacturer

Device Technologies Australia Pty Ltd