SDC HD CAPTURE RECORDER W/PRINTER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 STRYKER CANADA LP 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
    50937
  • 사례 위험등급
    II
  • 사례 시작날짜
    2009-11-04
  • 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
    Stryker endoscopy was aware that the sdc hd picture/video capture device would not be able to assign the correct time/date stamp for saved files after december 31st 2009. on january 1st 2010 the system date for all sdc hd units would re-start from october 1st 2001 and begin incrementing from that point onwards. this event would not affect how pictures or videos were captured using sdc hd during surgery however the system date would be incorrect and users would not be able to correct this issue without a software upgrade.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 240-050-890 (Lot serial: ALL LOT NUMBERS); Model Catalog: 240-050-888 (Lot serial: ALL LOT NUMBERS)
  • 제품 설명
    SDC HD Capture Device
  • Manufacturer

Manufacturer

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