Events

Device Recall INOmax DSIR Delivery System 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
    67947
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1528-2014
  • 사례 시작날짜
    2014-03-27
  • 사례 출판 날짜
    2014-05-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126644
  • 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 anomaly impacts the monitoring system of inomax dsir plus (software 3.0.0). when the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended no cell failure alarm will occur. in addition, an unintended no2 cell failure alarm may also occur. the no/no2 cell failure alarms are caused by an average no/no2 circuit concentration greater tha.
  • 조치
    Ikaria sent an Urgent Field Corrective Action letter via FedEx on March 27, 2014. The letter identified the issue, and requested that all INOmax DSIR with software version 3.0.0 be returned to Ikaria. Customers with questions were instructed to contact Ikaria Customer Care at 1-877-566-9466. For questions regarding this recall call 877-566-9466.

Device

Device Recall INOmax DSIR Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420,  DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including DC and VA.
  • 제품 설명
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the 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