Events

Device Recall Medtronic StealthStation S7 System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Navigation, Inc 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
    56013
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2029-2010
  • 사례 시작날짜
    2010-06-14
  • 사례 출판 날짜
    2010-07-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92424
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Neurological stereotaxic instrument - Product Code HAW
  • 원인
    Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.
  • 조치
    Customers were notified by letter on Jun 14, 2010, advising them of the problem. Instructions were provided to continue using existing retractable power cords until they could be replaced with non-retractable cords by Medtronic, beginning on Aug 17. Further information is available from the company by calling 800-595-9709.

Device

Device Recall Medtronic StealthStation S7 System
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, including 3 VA facilities. No military distribution. Foreign accounts in Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.
  • 제품 설명
    Medtronic StealthStation S7 System
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

Medtronic Navigation, Inc
  • 제조사 주소
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA