Events

Blood Gas and CoOx Electrolyte & Metabolyte Analyzers. 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
    34963
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1387-06
  • 사례 출판 날짜
    2006-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45026
  • 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 and Co-Ox Electrolyte & Metabolyte Analyzers - Product Code JFP
  • 원인
    Under certain circumstances, the abl 700 &800 series blood gas analyzers may experience leakage current into the measuring system. consequently, the analyzers intermittently provide incorrect (too low) result values for calcium (ca) and sodium (na).
  • 조치
    The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.

Device

Blood Gas and CoOx Electrolyte & Metabolyte Analyzers.
  • 모델명 / 제조번호(시리얼번호)
    All analyzers manufactured from 8/2004-9/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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