Events

Volcano FloWire Doppler Guidewire 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
    60842
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0935-2012
  • 사례 시작날짜
    2009-10-06
  • 사례 출판 날짜
    2012-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106630
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    Reports of no signal displayed on the monitor when flowire doppler guide wires were connected to the combomap.
  • 조치
    Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory. For questions regarding the use of the product. customers were instructed to contact their Sales Representative. For questions regarding this recall call 916-281-2790.

Device

Volcano FloWire Doppler Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Part number 1400; Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe
  • 제품 설명
    FloWire Doppler Guide wires. || Volcano Corporation, || Rancho Cardova, Ca. || The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.
  • Manufacturer
    Volcano Corporation

Manufacturer

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