Events

Device Recall GE, Optima CT660 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
    65958
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0023-2014
  • 사례 시작날짜
    2013-03-26
  • 사례 출판 날짜
    2013-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121035
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    Ge healthcare has recently become aware of a potential safety issue related with the dmpr function and screen saved images on your scanner which involves optima ct660, brivo ct385, discovery pet/ct 610, discovery pet/ct 710. the dmpr and screen save functionality may possibly generate the same series uid. it has been seen that some pacs may combine series under a patient using only the series uid.
  • 조치
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

Device

Device Recall GE, Optima CT660
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
  • 제품 설명
    GE, Optima CT660. || Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
  • 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