ARTAIS ZEE BIPLANE MN 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
    19495
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-12-11
  • 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
    For artis systems in conjunction with the artis table: the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap ring is used to secure the bolt. in rare cases it was identified that the snap ring is not properly fixed. in case of a missing or wrongly installed snap ring the bolt could slide out of its base and the table top carriage could slide to the floor.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10094143 (Lot serial: N/A); Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (Lot serial: N/A); Model Catalog: 10848283 (Lot serial: N/A); Model Catalog: 10848282 (Lot serial: N/A); Model Catalog: 10848281 (Lot serial: N/A); Model Catalog: 10848280 (Lot serial: N/A); Model Catalog: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A); Model Catalog: 5904466 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7555373 (Lot serial: N/A); Model Catalog: 10848355 (Lot serial: N/A); Model Catalog: 10848354 (Lot serial: N/A); Model Catalog: 10848353 (Lot serial: N/A); Model Catalog: 5904441 (Lot serial: N/A); Model Catalog: 59 17 054 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); M
  • 제품 설명
    ARTAIS ZEE BIPLANE MN;AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS Q;AXIOM ARTIS DBC;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS DFC;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;AXIOM ARTIS DFA;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;AXIOM ARTIS DBC MAGNETIC NAVIGATION;AXIOM ARTIS F
  • Manufacturer

Manufacturer

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