Events

Device Recall DICOM Query/Retrieve, version 1.1.4 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
    54621
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2781-2011
  • 사례 시작날짜
    2011-06-02
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88795
  • 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
    Software allows incorrect patient or patient history to be displayed.
  • 조치
    Medtronic Navigation sent a "FIELD SAFETY NOTICE" letter dated June 2, 2011 to all affected customers. The letter identified the product, problem and description of the corrective action. The letter states that Medtronic field representatives will visit each consumer/user and upgrade the version of DICOM Q/R to 1.1.5. Further information is available by contacting Medtronic Navigation Technical Services at 1-800-595-9709.

Device

Device Recall DICOM Query/Retrieve, version 1.1.4
  • 모델명 / 제조번호(시리얼번호)
    DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - USA (nationwide) -- including states of: TX, NC, ID, FL, OH, UT, CA, TN, IL, AZ, NE, LA, PA, OR, AR, MI, NJ, MD and countries of: Canada, Denmark, Finland, Great Britain, Hungary, Ireland, Japan, Korea, Netherlands, Poland, South Africa, Spain, and Taiwan.
  • 제품 설명
    DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. || Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture Archiving and Communication System (PACS) for patient DICOM scans. The user can then transfer the identified scan to a Medtronic StealthStation system.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • 제조사 주소
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • 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