Events

Device Recall Radiance Flex Blood Gas Anayzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Radiometer America 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
    36539
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0115-2007
  • 사례 시작날짜
    2006-07-06
  • 사례 출판 날짜
    2006-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48877
  • 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
    Blood Gas Analyzer - Product Code JQP
  • 원인
    Incorrect fi02 values: programming issue can cause incorrect values to be transmitted to the lis when : 1)- the fio2 result is edited in the manual sample processing mode--2)- an existing result is opened and fi02 is then edited and sent.....In both cases radiance will transmit the original fi02 value, not the value that was edited.
  • 조치
    The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.

Device

Device Recall Radiance Flex Blood Gas Anayzer
  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers: 914-418 and 914-426
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.
  • 제품 설명
    Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA