Events

INOmax DSIR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 INO Therapeutics (dba Ikaria) 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
    69635
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0575-2015
  • 사례 시작날짜
    2014-10-17
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131204
  • 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
    Apparatus, nitric oxide delivery - Product Code MRN
  • 원인
    An issue has been identified in the inomax dsir system that could result in monitored nitric oxide (no) concentration reporting lower than expected. this issue only pertains to those devices manufactured using a specific version of the monitoring circuit board.
  • 조치
    Ikaria contacted consignees by phone beginning 10/17/2014. A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.

Device

INOmax DSIR
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in states of: VA and PA only.
  • 제품 설명
    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
  • Manufacturer
    INO Therapeutics (dba Ikaria)

Manufacturer

INO Therapeutics (dba Ikaria)
  • 제조사 주소
    INO Therapeutics (dba Ikaria), 2902 Dairy Dr, Madison WI 53718-3809
  • 제조사 모회사 (2017)
    Mallinckrodt Plc
  • Source
    USFDA