Events

GE MR Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    59982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0148-2012
  • 사례 시작날짜
    2011-09-15
  • 사례 출판 날짜
    2012-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104146
  • 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
    Monitor, patient position, light-beam - Product Code IWE
  • 원인
    Ge healthcare has become aware of missing labels on the alignment lasers.
  • 조치
    GE Healthcare will execute a field action in which GE Healthcare Field Engineers will perform an inspection of all suspect MR systems. Any systems lacking any of the 3 laser warning labels will be remediated by applying the missing labels). We expect this field action will be completed by June 30, 2012. 1. Notification of all distributors and purchasers be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. The FDA district office coordinator noted below is to be included in the notifications. 2. Corrections be made at no cost to the purchasers.

Device

GE MR Systems
  • 모델명 / 제조번호(시리얼번호)
    5147788-5, 5139394, and 5139394-2; 2199859 and 2202900-6; 5148810 and 5373011; 5148810-2 and 5373011-2; 5148810-3, 5148810, and 5373011.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    GE Healthcare Signa, Discovery and Optima. || Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. || The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA