SYNGO.PLAZA 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    29256
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-11-19
  • 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
    Potential issue when using syngo.Plaza or syngo imaging xs and anatomical printing. anatomical printouts may not be printed in correct anatomical size. printouts may be printed in incorrect anatomical size when using syngo.Plaza or syngo imaging xs filming application to print in anatomical size with a printer not released for anatomical print. this may happen due to an invalid combination of printer and the syngo.Plaza or syngo imaging xs printer configuration file. printers which are marked in the attached list with "yes" for anatomical printing will not be affected by this issue. only these printers are validated to be used for anatomical printing.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10592457 (Lot serial: 100086); Model Catalog: 10592457 (Lot serial: 100168); Model Catalog: 104 96 279 (Lot serial: 3028); Model Catalog: 104 96 279 (Lot serial: 3127); Model Catalog: 075 020 29 (Lot serial: 9749); Model Catalog: 075 020 29 (Lot serial: 11614); Model Catalog: 075 020 29 (Lot serial: 13357); Model Catalog: 10592457 (Lot serial: 100008); Model Catalog: 10592457 (Lot serial: 100001); Model Catalog: 10592457 (Lot serial: 100102); Model Catalog: 10592457 (Lot serial: 100018)
  • 제품 설명
    Syngo.Plaza
  • Manufacturer

Manufacturer

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