Events

ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConMed Linvatec 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-00224-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00224-1
  • 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 has determined there is potential for the keyboard to lockup during operation due to a software issue in the vp1600 console. if during use the caps lock/num lock is pressed, the vp1600 software could potentially give the appearance of being locked up, but is actually unresponsive only to keyboard inputs. the vp1600 is still presenting a live image on the main display but may not be able to capture an image frame for record storage using the keyboard.
  • 조치
    Please contact ConMed Linvatec Australia to schedule a return date for repairing the affected unit. A loan unit will be provided by ConMed Linvatec if needed during the repair. VP1600 can continued to be used until repaired if the manufacturer’s recommendations and instructions detailed in the Product Manual, for the safe handling and use of the device is followed.

Device

ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)
  • 모델명 / 제조번호(시리얼번호)
    ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)Affected Serial numbers: 75659, 75804, 76126, 75805, 76116, 12008, 72902, 76009, 12043, 12036, 75657, 75658 and 12015ARTG: 126243
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd