Events

Device Recall Engstrom Carestation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex - Ohmeda, 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
    37105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0784-2007
  • 사례 시작날짜
    2007-02-02
  • 사례 출판 날짜
    2007-05-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49921
  • 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
    Critical Care Ventilator - Product Code CBK
  • 원인
    There are two unique conditions with the engstrom carestation that require corrective action. these include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
  • 조치
    Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.

Device

Device Recall Engstrom Carestation
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: CBCH00101, CBCH00110, CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686, CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru CBCK00526, CBCK00535
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY.
  • 제품 설명
    GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • 제조사 주소
    Datex - Ohmeda, Inc, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53707-7550
  • Source
    USFDA