Events

MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS CANADA LIMITED - HEALTHCARE 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
    28771
  • 사례 위험등급
    I
  • 사례 시작날짜
    2011-09-01
  • 사례 국가
    Canada
  • 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
    Lowering the swivel arm with "object table" while an operator's or a patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. the movement of the swivel arm may also cause an injury. during a biopsy examination the swivel arm of the system might be tilted to somewhere between +15 and -15 degrees and when starting the examination to acquire stereo images the swivel arm may automatically move between +15 to -15 degrees. this movement may cause body parts to be pinched or otherwise injured particularly with seated or recumbent patients.

Device

MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    HC