Events

Device Recall Medtronic 0arm 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
    74153
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2082-2016
  • 사례 시작날짜
    2016-03-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146523
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • 원인
    It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
  • 조치
    Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.

Device

Device Recall Medtronic 0arm Imaging System
  • 모델명 / 제조번호(시리얼번호)
    Model No. BI-700-00027 and BT-700-00028
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Medtronic 0-arm Imaging mobile x-ray system. || Model Numbers - B1-700-00027, || B1-700-00028
  • 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