Events

Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray 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
    49501
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2034-2008
  • 사례 시작날짜
    2008-06-30
  • 사례 출판 날짜
    2008-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73640
  • 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
    Fluoroscopic Image-Intensified X-Ray System - Product Code JAA
  • 원인
    Failure to of affected units to comply with eer/akr limits due to misinterpretation of the measurement requirements specified in 21 cfr 1020.32 (d) (3) (iii).
  • 조치
    Medtronic Navigation notified service engineers to retest units for compliance.

Device

Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System
  • 모델명 / 제조번호(시리얼번호)
    S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, DC, LA, FL. IN, OH, PA, VA
  • 제품 설명
    BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System || Generating 2D and 3D images of human anatomy for surgical applications.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • 제조사 주소
    Medtronic Navigation, Inc., 300 Foster St, 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