Events

Device Recall Greenlight II laryngeal scope handle and cartridge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Signs Colorado 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
    57464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1024-2011
  • 사례 시작날짜
    2010-12-20
  • 사례 출판 날짜
    2011-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96283
  • 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
    Laryngoscope, rigid - Product Code CCW
  • 원인
    Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
  • 조치
    Healthcare Systems sent an URGENT MEDICAL DEVICE CORRECTION letter dated December 20, 2010, to all affected consignees advising them of the possible problem and giving them interim safety instructions until new battery cartridges were available. Customers were instructed to complete and return the Confirmation Form which was included with the letter. For information regarding this recall call 973-956-5300.

Device

Device Recall Greenlight II laryngeal scope handle and cartridge
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, MA, MN, MO, NH, NJ, NY, OH, OK, SC, TN, TX, WA, and WV and the countries of Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK
  • 제품 설명
    Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. || Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • 제조사 주소
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA