Events

Device Recall Carescape Patient Data Module v2.0 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
    63655
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0524-2013
  • 사례 시작날짜
    2012-02-17
  • 사례 출판 날짜
    2012-12-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114421
  • 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, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Ge healthcare became aware of two issues with the patient data module using version 2.0 software that may impact patient care.
  • 조치
    Consignees were sent on 2/17/2012 three GE Healthcare "Important Product Information" letters dated 10/17/ 2011. The letters were addressed to Healthcare Administrator/Risk Manager, Director of Biomedical Engineering, and Chief of Nursing. The letters described the Issue, Instructions, Affected Product Details, Product Correction and Contact Information.

Device

Device Recall Carescape Patient Data Module v2.0
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
  • 제품 설명
    GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
  • 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