Events

GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 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
    66254
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0021-2014
  • 사례 시작날짜
    2013-08-16
  • 사례 출판 날짜
    2013-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121897
  • 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
    Ge healthcare has become aware of a potential safety issue involving missing screws in the overhead video monitor suspension of the advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems.
  • 조치
    Consignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).

Device

GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.
  • 제품 설명
    GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. || Intended for general purpose diagnostic fluoroscopy and radiography studies.
  • 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