Events

Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher & Paykel Healthcare 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
    34248
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0696-06
  • 사례 시작날짜
    2005-12-20
  • 사례 출판 날짜
    2006-03-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43335
  • 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
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • 원인
    Risk of fire. the manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. this may lead to a potential risk of fire.
  • 조치
    On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.

Device

Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
  • 모델명 / 제조번호(시리얼번호)
    Affected lots for all catalogue numbers: 041101-050331(inclusive).
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
  • 제품 설명
    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc
  • 제조사 주소
    Fisher & Paykel Healthcare Inc, 22982 Alcalde Drive 101, Laguna Hills CA 92653
  • Source
    USFDA