Events

HamiltonMR1 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
    75336
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0666-2017
  • 사례 출판 날짜
    2016-11-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150064
  • 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
    Oxygen tubing and the oxygen connector of the hamilton-mr1 could potentially become loose during the preparation for ventilation.
  • 조치
    Hamilton Medical sent a letter dated September 6, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Hamilton Medical will update each affected Hamilton-MR1 ventilators by installing a new oxygen mixer mounting plate with the correct screws at no cost to each facility. A Hamilton Medical Field Service Technician will contact customers soon to schedule a convenient time to install the hardware upgrade. Customers may also call 1-800-426-6331, option #2 to be issued an RGA for return to the service center for the upgrade kit to be installed. Customers with questions should call 817-909-0308.

Device

HamiltonMR1
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers between 2001 and 2103
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Hamilton-MR1 Ventilator: Catalog# 161010 || The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
  • Manufacturer
    Hamilton Medical, Inc.

Manufacturer

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