Events

Device Recall HamiltonG5 Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hamilton Medical 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
    61238
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1185-2012
  • 사례 시작날짜
    2012-02-06
  • 사례 출판 날짜
    2012-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107632
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • 원인
    Hamilton-g5 ventilators with software version v2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
  • 조치
    Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.

Device

Device Recall HamiltonG5 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    All Hamilton 5
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
  • 제품 설명
    HAMILTON G5 ventilators with software version V2.0x. || Hamilton Medical AG, Switzerland || Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. || Product Usage: || Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • 제조사 주소
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-3008
  • 제조사 모회사 (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA