Events

Optima MR450W with GEM. 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
    61413
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1492-2012
  • 사례 시작날짜
    2012-04-12
  • 사례 출판 날짜
    2012-05-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108026
  • 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
    Coil, magnetic resonance, specialty - Product Code MOS
  • 원인
    Ge healthcare is conducting a recall on optima mr450w with gem. during scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. if a second and compounding issue of improperly routed rear pedestal air supply hose is also present, routed in such a way to cause the hose to come in contact with the overheated gradient lead.
  • 조치
    GE Healthcare is not sending a Communication Letter to customers. There is no plan to contact customers with an affected Optima MR450W with GEM system. A GE Healthcare Field Service Engineer will be dispatched to sites to inspect and correct all potentially affected systems. As an effectiveness check, GE Healthcare will track all service requests for the field action to completion. For any questions or additional information, call 262-548-2608.

Device

Optima MR450W with GEM.
  • 모델명 / 제조번호(시리얼번호)
    HM0227 HM0243 HM0245 HM0255 HM0290 HM0292 HM0296 HM0301 HM0315 HM0316 HM0321 HM0343 HM0271 HM0339 HMO293 HM0287 HM0263 HM0236 312 HM0322 HM0331 HM0332 357 HM0247 HM0250 HM0253 HM0261 HM0326 HMO300 HM0242 HM0249 HM0251 HM0254 HM0309 HM0310 HM0334 HM0338 HM0344 HM0347 HM0262 HM0323
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) including the states of :CO, FL, IA, MA ,MN, NJ, NY, NC, OH, TX. and the countries of BRAZIL., BRITAIN, FINLAND, FRANCE, GREAT GERMANY, ITALY, SAUDI ARABIA, SWEDEN, SPAIN, KUWAIT, and SWIITZERLAND.
  • 제품 설명
    GE Healthcare, Optima MR450W with GEM. || Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
  • 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