Events

Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems Information Technologies, Inc. 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
    78918
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0487-2018
  • 사례 시작날짜
    2018-01-11
  • 사례 출판 날짜
    2018-01-25
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160858
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    Carescape central station (cscs) software version 2.0.2 units may experience unexpected no comm (no communication) and network communication issues after boot-up or system restart.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.

Device

Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
  • 제품 설명
    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 || The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
  • Manufacturer
    GE Medical Systems Information Technologies, Inc.

Manufacturer

GE Medical Systems Information Technologies, Inc.
  • 제조사 주소
    GE Medical Systems Information Technologies, Inc., 8200 W Tower Ave, Milwaukee WI 53223-3219
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA