Events

MACLAB 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
    25951
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0784-03
  • 사례 시작날짜
    2003-04-14
  • 사례 출판 날짜
    2003-04-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-06-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26762
  • 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
    Monitor, Bed Patient - Product Code KMI
  • 원인
    There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
  • 조치
    A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.

Device

MACLAB
  • 모델명 / 제조번호(시리얼번호)
    The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.
  • 제품 설명
    MAC-LAB (Classic) systems
  • 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, Milwaukee WI 53223
  • Source
    USFDA