Events

Device Recall RapidLab1200 System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bayer Healthcare, LLC (Diagnostics Division) 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
    34505
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0684-06
  • 사례 시작날짜
    2006-01-20
  • 사례 출판 날짜
    2006-03-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44156
  • 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
    When stored data is recalled from memory, the results do not agree with the original results. software anomaly: a calculation error occurs when using the correlation adjustment feature on the rapidlab 1200 systems with software versions 1.0, 1.01, or 1.02. the correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
  • 조치
    Support Bulletins and Customer Bulletins were e-mailed to all Bayer HealthCare LLC Branches on 1/20/06 for distribution to the end user facilities (medical facilities).

Device

Device Recall RapidLab1200 System
  • 모델명 / 제조번호(시리얼번호)
    All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
  • 제품 설명
    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • 제조사 주소
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591
  • Source
    USFDA