Events

Device Recall CIC Pro System 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
    37309
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0891-2007
  • 사례 시작날짜
    2007-01-24
  • 사례 출판 날짜
    2007-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50585
  • 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
    Clinical Information Center - Product Code DSI
  • 원인
    Alarm and reboot problems: two separate issues could occur with the cic pro system when used with telemetry. each issue occurs in software version v4.1 only; a) the system may experience a loss of audible alarms when operating system memory resources reach 170mb and/or b) the system may intentionally or unexpectedly reboot .
  • 조치
    GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.

Device

Device Recall CIC Pro System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers of Software Version 4.1
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)
  • 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