Events

IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system) 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-2013-RN-01127-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01127-1
  • 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
    The manufacturer, intuitive surgical has identified that the metalized coating on the is3000 hd lamp module (pn ins-950093-05) may be incompatible with the illuminator (pn ins-951183-06) control board, leading to a red preventive maintenance advisory (pma) that shows up on all monitors and cannot be dismissed by the user. in rare circumstances the illuminator may be damaged or the lamp module might not illuminate. there have been no reports of lamp failures associated with this issue.
  • 조치
    Device Technologies is advising users that this issue does not affect lamps with plastic coating. Affected lamps with metal finish may continue to be used until a replacement is received. If an error message is displayed, users should contact their Device Technologies representative.

Device

IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci S...
  • 모델명 / 제조번호(시리얼번호)
    IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)Part Number (PN): INS-950093-05ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd