Events

Device Recall Surgical Navigation 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
    57696
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1558-2011
  • 사례 시작날짜
    2010-12-22
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97017
  • 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
    Position sensor unit may generate tracking errors or may stop tracking immediately.
  • 조치
    The firm, Medtronic, sent a "Product Correction Notification" letter dated December 22, 2010, to all US Consignees/Customers on December 23, 2010 and foreign Consignees/Customers on December 27, 2010. The letter described the product, problem and actions to be taken. The customer were instructed to discontinue use of the impacted navigation system(s) until a replacement camera (PSU) is installed. A Medtronic Navigation Representative will visit each facility to remove the navigation camera and install a replacement. If you have any questions, contact your Medtronic Navigation Representative or Medtronic Navigation Technical Support services at 1-800-595-9709 or +1-720-890-3200.

Device

Device Recall Surgical Navigation System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: P703048, P703049, P703050, P703054, P703055, P703060, P703061, P703063, P703066, P703068, P703070, P703076, P703077, P703079, P703114, P703140, P703141, P703143.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa.
  • 제품 설명
    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. || The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

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