Events

Device Recall DISCOVERY MR450 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
    59232
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3123-2011
  • 사례 시작날짜
    2011-07-29
  • 사례 출판 날짜
    2011-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102278
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Ge healthcare has become aware of two potential safety issues associated with mr products (optima mr450w, discovery mr450, discovery mr750, brivo mr355, optima mr360) that may impact patient safety. 1) inline post-processed (i.E. automated post-processing) image locations are not correctly annotated under some conditions. 2) reference images displayed in functool fibertrak do not match with.
  • 조치
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.

Device

Device Recall DISCOVERY MR450
  • 모델명 / 제조번호(시리얼번호)
    00000299294MR9 00000299320MR2 00000299339MR2 00000299491MR1 00000299503MR3 00000299520MR7 00000299522MR3 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299644MR5 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299852MR4 00000299952MR2 00000300038MR7 00000300473MR6 00000300493MR4 00000300494MR2 00000300564MR2 00000300565MR9 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300671MR5 00000300688MR9 00000300722MR6 00000300723MR4 00000300794MR5 00000300847MR1 00000300866MR1 00000300867MR9 00000300898MR4 00000300900MR8 00000300930MR5 00000299684MR1 00000299685MR8 00000299825MR0 00000300796MR0 00000300298MR7 00000300865MR3 00000300591MR5 00000299261MR8 00000299341MR8 00000299464MR8 00000300589MR9 00000300966MR9 00000299686MR6 00000300037MR9 00000300297MR9
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WT, WY. and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROAT IA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUKEYand UNITED KINGDOM.
  • 제품 설명
    GE Healthcare, Discovery MR450 || Product Usage: The Discovery MR450w 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 images, parametric maps, and/or spectra, dynamic images of the structures and/ or functions of the entire body including, but 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 Discovery 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