Events

Medtronic Navigation Oarm O2 Surgical Imaging System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Navigation, Inc.-Littleton 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
    75279
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0070-2017
  • 사례 시작날짜
    2016-09-22
  • 사례 출판 날짜
    2016-10-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149921
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    O-arm o2 surgical imaging system spatial calibration may be erroneous in stealth station navigated images.
  • 조치
    Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.

Device

Medtronic Navigation Oarm O2 Surgical Imaging System
  • 모델명 / 제조번호(시리얼번호)
    Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930  C0981  C0986  C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
  • 제품 설명
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 || Product Usage: || The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
  • Manufacturer
    Medtronic Navigation, Inc.-Littleton

Manufacturer

Medtronic Navigation, Inc.-Littleton
  • 제조사 주소
    Medtronic Navigation, Inc.-Littleton, 300 Foster Street, Littleton MA 01460-2017
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA