Events

Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nova Biomedical Corporation 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
    77532
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2732-2017
  • 사례 시작날짜
    2017-06-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156306
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • 원인
    Software- scheduled a-qc analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the a-qc test results.
  • 조치
    Nova Biomedical issued Urgent Field Correction Notice on June 19, 2017, to all affected customers. The letter advises users of the problem and Nova Biomedical or an authorized Nova Biomedical representative will schedule a no charge update of your Stat Profile Prime Analyzer software to version VI1.0.883.0. A representative will contact customers to schedule this update. Questions: contact Nova Biomedical Technical Support at 1-800-545-6682, in Canada contact us at 1-800-263-5999, or outside of N. America contact your authorized Nova Biomedical subsidiary or distributor. For questions regarding this recall call 781-647-3700.

Device

Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Pr...
  • 모델명 / 제조번호(시리얼번호)
    All current software versions
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana Greece Guatemala Guyana Honduras Hong Kong Hungary ICELAND India Iran Israel Italy Ivory Coast Japan Jordan Kenya Korea Latvia Macedonia Malaysia Mexico Nepal Netherlands Nigeria Pakistan Pakistan Palestine Peru Philippines Poland Puerto Rico Republic of Panama Republica Dominicana Russia Saudi Arabia Slovak Republic Slovenia South Africa Sri Lanka Switzerland Taiwan Thailand The Netherlands Trinidad,W.I. Tunisia Turkey UK Uruguay Vietnam
  • 제품 설명
    Nova Biomedical Stat Profile Prime Analyzer as follows: || PN 52855 Stat Profile Prime ABG Analyzer || PN 53655 Stat Profile Prime ABG Analyzer with Scanner || PN 52856 Stat Profile Prime CCS Analyzer || PN 53656 Stat Profile Prime CCS Analyzer with Scanner || PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner || PN 52857 Stat Profile Prime CCS Comp Analyzer || Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • 제조사 주소
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • 제조사 모회사 (2017)
    Nova Biomedical Corporation
  • Source
    USFDA