Events

Device Recall Fixation Kit N20 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
    71739
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2417-2015
  • 사례 시작날짜
    2015-07-16
  • 사례 출판 날짜
    2015-08-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138895
  • 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
    Monitor, carbon-dioxide, cutaneous - Product Code LKD
  • 원인
    When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
  • 조치
    Radiometer sent a Product Notification letter dated July 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In the letter the firm requests that inventory be checked and removed for any the identified lot numbers for Fixation kit N20. The firm requests that the products be discarded. The letter states to complete p.2 and return it to their Radiometer representative. If you have any questions contact Radiometer America Technical Support at 1-800-736-0600 opt.4.

Device

Device Recall Fixation Kit N20
  • 모델명 / 제조번호(시리얼번호)
    Model #: 905-873   Lots: 407221, 407231, 407241, 407251, 408041, 408191, 408201, 408211, 408231, 408232, 408261, 408271, 409021, 409101, 409231, 409291, 410021, 410141, 410281, 411171, 411201, 411261, 412021, 412111, 412161, 412201, 501081, 501131, 501191, 501311, 502031, 502101, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504031, 504081, 504111, 504271, 505041, 505061, 505141, 505181
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Canada, Spain, France, Great Britain, Philippines, Netherlands, Japan, China, Australia, Denmark, South Africa, Germany, Qatar, Turkey, Hong Kong, Costa Rica, Austria, Finland, Indonesia, Norway, Malaysia, Belgium, Czech Republic, Hungry, United Arab Emirates, Poland, Colombia, Belgium and Malta.
  • 제품 설명
    Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • 제조사 주소
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA