Events

Device Recall GE Healthcare Precision 500D Classical R & F system. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    71574
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2120-2015
  • 사례 시작날짜
    2015-06-12
  • 사례 출판 날짜
    2015-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138247
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    A reported incident of a monitor that fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. recall affects the single and dual lcd monitor suspensions used on precision 500d classical r & f system, precision rxi 23a/32a analog system, precision rxi digital system and precision mpi fluoroscopic imaging systems.
  • 조치
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s). 1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. 3. Contact your GE Healthcare representative to inform them of any loose or missing screws. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare Precision 500D Classical R & F system.
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
  • 제품 설명
    GE Healthcare Precision 500D Classical R & F system.
  • Manufacturer
    GE Healthcare

Manufacturer

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