Events

Device Recall The HAMILTON T1 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
    64117
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0741-2013
  • 사례 시작날짜
    2012-12-19
  • 사례 출판 날짜
    2013-01-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115383
  • 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
    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a hamilton t1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
  • 조치
    Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215

Device

Device Recall The HAMILTON T1
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 1.1.2 and below; Part numbers 161005, 161006.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including the country of Switzerland.
  • 제품 설명
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. || The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • 제조사 주소
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-4123
  • 제조사 모회사 (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA