Events

Device Recall GE Definium 8000 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
    49504
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1822-2008
  • 사례 시작날짜
    2008-03-07
  • 사례 출판 날짜
    2008-09-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73650
  • 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
    Digital Radiographic System - Product Code KPR
  • 원인
    Loss of image data: software anomaly in the processing software on the definium 8000 system may impact patient safety when using the volumerad advanced application (option). the slice visualization of volumerad exams acquired on the wallstand receptor will be offset by 17mm. this prevents the visualization of anatomy within a distance of 17mm from the wallstand patient barrier (receptor cover).
  • 조치
    GE sent a Product Safety Notification, dated March 7, 2008, to all customers. The letter described the safety issue, products affected, and stated that a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification.

Device

Device Recall GE Definium 8000
  • 모델명 / 제조번호(시리얼번호)
    00000002047M39, 00000005487M34, 00000096986DP%, 00000100740WK6, 00000TA41882-7, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA42274-8, 00000TA42869-6, 00001004330WK5, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004510WK2, 00001004513WK6, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004768WK6, 00001004770WK2, 00001004772WK8, 00001005020WK1, 00001005022WK7, 00001005024WK3, 00001005030WK0, 00001005031WK8, 00001005035WK9, 00001005181WK1, 00001005182WK9, 00001005188WK6, 00001005260WK3, 00001005339WK5, 00001005758WK6, 00001005914WK5, 00001006042WK4, 00001006474WK9, 00001006635WK5, 00001006637WK1, 00001006638WK9, 00001006668WK6, 00001006871WK6, 00001007161WK1, 00001007166WK0, 00001007403WK7, 00001007404WK5, 00001007480WK5, 00001007536WK4, 00001007644WK6, 00001007650WK3, 00001007907WK7, 00001008312WK9, 00001008314WK5, 00001008497WK8, 00001008684WK1, 00001008807WK8, 00001008813WK6, 00001009140WK3, 00001009143WK7, 00001009145WK2, 00001009216WK1, 00001009268WK2, 00001009375WK5, 00001009380WK5, 00001009382WK1, 00001009709WK5, 00001009818WK4, 00001009875WK4, 00001009934WK9, 00001009976WK0, 00001010085WK7, 00001010099WK8, 00001010161WK6, 00001010239WK0, 00001010294WK5, 00001010295WK2, 00001010297WK8, 00001010431WK3, 00001010488WK3, 00001010524WK5, 00001010628WK4, 00001010629WK2, 00001010687WK0, 00001010693WK8, 00001010695WK3, 00001010906WK4, 00001010907WK2, 00001010964WK3, 00001011084WK9, 00001011085WK6, 00001011092WK2, 00001011215WK9, 00001011285WK2, 00001011289WK4, 00001011386WK8, 00001011455WK1, 00001011488WK2, 00001011490WK8, 00001011647WK3, 00001011654WK9, 00001011700WK0, 00001011712WK5, 00001011822WK2, 00001011825WK5, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011832WK1, 00001012012WK9, 00001012119WK2, 00001012286WK9, 00001012449WK3, 00001012450WK1, 00001012453WK5, 00001012923WK7, 00001013064WK9, 00001013067WK2, 00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013223WK1, 00001013334WK6, 00001013336WK1, 00001013622WK4, 00001014310WK5, 00001014936WK7, 00001016147WK9
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.
  • 제품 설명
    GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.
  • 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