Events

Device Recall pcFM Software Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Volcano Corporation 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
    60867
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0973-2012
  • 사례 시작날짜
    2010-06-11
  • 사례 출판 날짜
    2012-02-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106686
  • 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
    ComboMap System pcFM - Product Code IYO
  • 원인
    Internal review of validation of pcmf software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
  • 조치
    The firm, Volcano Corporation, sent an "IMPORTANT PRODUCT INFORMATION" letter dated June 17, 2010 to all customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the pcFM Software kit to: Volcano Corporation at 2870 Kilgore Road, Rancho Cordova, CA 95670 and contact (800) 228-4728 for instructions on returning the product. The customers were also instructed to complete and return the attached Customer Reply Letter form to Volcano even if they no longer use the pcFM Software Kit via fax to Volcano Customer Support at (916) 638-8812. If you have any questions, contact your Sales Representative or Customer Service at (800) 228-4728.

Device

Device Recall pcFM Software Kit
  • 모델명 / 제조번호(시리얼번호)
    Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
  • 제품 설명
    Volcano pcFM Software Kit ; || Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. || The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • 제조사 주소
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA