VP 1600 HD STILL CAPTURE SYSTEM 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 CONMED CANADA 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
    89971
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-03-11
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Through the conmed linvatec complaint system conmed linvatec has received sporadic complaints where the vp1600 still capture console software may give the appearance of being fully locked up but is actually unresponsive with certain keyboard inputs. the vp1600 is still fully functional and presents a full motion image on the main display monitor but may not be able to capture a still image frame (picture) for record storage purposes using the keyboard. the user can still capture a still image using the camera head unit. the user may also feel compelled to turn off and reboot the system which will render a display loss during the rebooting process. this is a still image capture system without any direct patient contact.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: VP1600 (Lot serial: All serial numbers)
  • 제품 설명
    HD STILL CAPTURE SYSTEM
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC