Events

Device Recall GE Precision MPi 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Regulatory Insight, 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
    72515
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0753-2016
  • 사례 시작날짜
    2008-07-01
  • 사례 출판 날짜
    2016-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141343
  • 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
    It was discovered that the remote touch panel (rtp) of the ge precision mpi x-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
  • 조치
    Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.

Device

Device Recall GE Precision MPi
  • 모델명 / 제조번호(시리얼번호)
    NRT no.: 02980000
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
  • 제품 설명
    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
  • Manufacturer
    Regulatory Insight, Inc

Manufacturer

Regulatory Insight, Inc
  • 제조사 주소
    Regulatory Insight, Inc, 33 Golden Eagle Ln, Littleton CO 80127-5745
  • 제조사 모회사 (2017)
    Regulatory Insight Inc
  • Source
    USFDA