Events

Device Recall Solar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 General Electric Medical Systems Information Technology 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
    27558
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0092-04
  • 사례 시작날짜
    2002-06-14
  • 사례 출판 날짜
    2003-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30066
  • 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
    Detector And Alarm, Arrhythmia - Product Code DSI
  • 원인
    Various user settings may change without an audible warning or visual indication. examples of settings that may change are pacemaker detection which may turn from on to off, selected ecg leads for display, and selected gain settings for a selected waveform.
  • 조치
    A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem.

Device

Device Recall Solar
  • 모델명 / 제조번호(시리얼번호)
    All devices with Solar 8000M software versions 3A, 3B or 3C are affected
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The devices were distributed nationwide in the United States and worldwide.
  • 제품 설명
    Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
  • Manufacturer
    General Electric Medical Systems Information Technology

Manufacturer

General Electric Medical Systems Information Technology
  • 제조사 주소
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Source
    USFDA