Events

Device Recall Definium 5000 Xray System 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
    51490
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1118-2009
  • 사례 시작날짜
    2009-03-24
  • 사례 출판 날짜
    2009-09-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80534
  • 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
    Stationary X-Ray System - Product Code KPR
  • 원인
    A defect in the aec board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.
  • 조치
    A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.

Device

Device Recall Definium 5000 Xray System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 00000GEHC00049, 00000GEHC00011, 00000GEHC00009 00000GEHC00035 00000GEHC00041 00000GEHC00028 00000GEHC00026 00000GEHC00078 00000GEHC00051 00000GEHC00043 00000GEHC00008 00000GEHC00016 00000GEHC00013 00000GEHC00058 00000GEHC00110 00000GEHC00120 00000GEHC00042 00000GEHC00047 00000GEHC00069 00000GEHC00057 00000GEHC00019 00000GEHC00066 00000GEHC00085 00000GEHC00046 00000GEHC00076 00000GEHC00015 00000GEHC00018 00000GEHC00124 00000GEHC00095 00000GEHC00022 00000GEHC00100 00000GEHC00125 00000GEHC00117 00000GEHC00027 00000GEHC00112 00000GEHC00054 00000GEHC00062 00000GEHC00119 00000GEHC00118 00000GEHC00048 00000GEHC00089 00000GEHC00114 00000GEHC00121 00000GEHC00107 00000GEHC00108 00000GEHC00036 00000GEHC00030 00000GEHC00045 00000GEHC00017 00000GEHC00064 00000GEHC00075 00000GEHC00077 00000GEHC00115 00000GEHC00053 00000GEHC00106 00000GEHC00007 00000GEHC00021 00000GEHC00023 00000GEHC00065 00000GEHC00020 00000GEHC00083 00000GEHC00105 00000GEHC00111 00000GEHC00031 00000GEHC00025 00000GEHC00104 00000GEHC00067 00000GEHC00133 00000GEHC00101 00000GEHC00072 00000GEHC00024 00000GEHC00087 00000GEHC00059 00000GEHC00012 00000GEHC00068 00000GEHC00034 00000GEHC00123 00000GEHC00073 00000GEHC00050 00000GEHC00113 00000GEHC00052 00000GEHC00006 00000GEHC00005 00000GEHC00131, and 00000GEHC00131.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Definium 5000 X-ray System, model number 5220493 and 5220393-2
  • 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