Events

Device Recall ABL700 Flex Series Analyzer 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
    46686
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1653-2008
  • 사례 시작날짜
    2008-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67927
  • 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
    Human Blood Analyzer - Product Code CHL
  • 원인
    Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. this may cause the operator to perform measurements and obtain questionable results.
  • 조치
    On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.

Device

Device Recall ABL700 Flex Series Analyzer
  • 모델명 / 제조번호(시리얼번호)
    ABL700 Series (902-441)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.
  • 제품 설명
    ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).
  • Manufacturer
    Radiometer America Inc

Manufacturer

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