Device Recall ABL 80 COOX SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sendx Medical 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
    52791
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0150-2010
  • 사례 시작날짜
    2009-02-20
  • 사례 출판 날짜
    2009-11-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Analyzer - Product Code CHL
  • 원인
    Inverness have recently become aware of a potential error contained in v1.30 and v1.31 software for the abl 80 co-ox platform. the error can occur if the analyzer is set to automatically upload patient records to radiance or an his/lis system. this can result in the reporting of incorrect results for one or more co-ox derived parameters. incorrect results can be displayed on the screen and the.
  • 조치
    Radiometer sent out a letter to consignees informing them of public reason for recall, and telling them that they have provided a copy of the upgrade software and instructions to correct this potential problem immediately. Software upgrade instructions were included with the recall letter. Consignees were informed that if they preferred that their local service representative perform the upgrade, to follow the Instructions for disabling auto upload of patients records. SOFTWARE UPGRADE INSTRUCTIONS: The upgrade software must be installed via the Software Upgrade option under Menu>Utilities>Software Upgrade. It is not a "boo table" CD. ~The Upgrade process will take approximately 10 minutes. The analyzer should be allowed to complete the entire process without user interaction. Do not attempt to turn the analyzer on or off manually at any time during the process. ~The upgrade process will include the following general steps: 1. Automatic power down and reboot of the analyzer 2. File transfer process which includes a variety of progress bars to communicate the status 3. Automatic power down and reboot of the analyzer a second time 4. A dialog box on the main menu screen that states, "ABL80 FLEX software has been upgraded to version 1.32." This signifies a successful upgrade process. ~If a solution pack and a sensor cassette are already installed on the analyzer, their installation status will not be affected by the software upgrade. ~All stored data will be retained in all logs They were also asked to complete and return the attached fax form, with their signature, to 1-800-736-0601. If their were any questions regarding the letter, or upgrade, to contact Techline at 1-800-736-0600 opt.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number: 393-841 all serial numbers are affected.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH
  • 제품 설명
    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 || Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI || The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA