Events

Samsung GM60A40S 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NeuroLogica Corporation 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
    72171
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0263-2016
  • 사례 시작날짜
    2015-09-14
  • 사례 출판 날짜
    2015-11-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140082
  • 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, mobile - Product Code IZI
  • 원인
    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. the system can be stopped by releasing the drive handle or by pressing the emergency switch. proper behavior is re-enabled when the system is rebooted.
  • 조치
    An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.

Device

Samsung GM60A40S
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E,  50EAM9BG200007F
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of NC, OH, MA, and MO.
  • 제품 설명
    Samsung GM60A-40S || Intended for use in generating radiographic images of human anatomy.
  • Manufacturer
    NeuroLogica Corporation

Manufacturer

NeuroLogica Corporation
  • 제조사 주소
    NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
  • 제조사 모회사 (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA