LEICA M525 F50 SURGICAL MICROSCOPES 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LEICA MICROSYSTEMS 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
    27214
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-12-04
  • 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
    Leica microsystems (schweiz) ag evaluated data of an internal report showing that it is possible an unspecified behaviour of the optional xy-unit for the leica m525 f50 and leica m525 c50. to date have not received any customer complaints involving a malfunction in the xy unit. by moving the xy-joysticks of the handle or the footswitch diagonally it is possible that the xy-unit will unintentionally proceed in one direction until the end stop is reached. consecutive entries in diagonal direction will contribute to the probability to stipulate this problem. after the xy movement is stopped by end stop or interruption through orthogonal xy-joystick command the xy-unit can be operated normally.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: M525 F50 (Lot serial: 271212001); Model Catalog: M525 F50 (Lot serial: 60312001); Model Catalog: M525 F50 (Lot serial: 110513001); Model Catalog: M525 F50 (Lot serial: 30613001)
  • 제품 설명
    LEICA M525 F50 SURGICAL MICROSCOPES
  • Manufacturer

Manufacturer