Events

Device Recall COMPAX 40E Xray Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    52720
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0457-2010
  • 사례 시작날짜
    2009-07-30
  • 사례 출판 날짜
    2009-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83813
  • 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
    Non-Tilting Powered Radiographic Table - Product Code IZZ
  • 원인
    Ge healthcare has recently become aware that table lock safety features, which are provided with compax 40e x-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.
  • 조치
    Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.

Device

Device Recall COMPAX 40E Xray Systems
  • 모델명 / 제조번호(시리얼번호)
    SYSTEM SERIAL  00000059301ES2  00000059308ES7  00000059350ES9  00000059655ES1  00000059657ES7  00000059682ES5  00000059699ES9  00000059701ES3  00000061281ES2  00000061285ES3  00000061288ES7  00000061292ES9  00000061312ES5  00000063191ES1  00000063197ES8  00000063200ES0  00000063201ES8  00000063202ES6  00000063218ES2  00000064023ES5  00000064031ES8  00000064045ES8  00000064050ES8  00000065211ES5  00000065212ES3  00000066155ES3  00000068507MA3  00000068516MA4  00000068518MA0  00000069848MA0  00000071567MA2  00000071568MA0  00000071569MA8  00000076137MA9  00000078106MA2  00000078109MA6  00000078110MA4  00000079274MA7  00000062896ES6  00000062904ES8  00000062905ES5  00000062907ES1  00000062908ES9  00000064086ES2  00000064683ES6  00000065711ES4  00000066419MA3  00000068887MA9  00000068890MA3  00000068894MA5  00000068899MA4  00000069099MA0  00000069872MA0  00000069881MA1  00000069905MA8  00000069906MA6 907276H02A 00000061271ES3 907580EF2 00000059667ES6 907458CAN 00000065215ES6 907458MDA1 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.
  • 제품 설명
    GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. || Intended to be used for general purpose radiography and tomography.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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