Events

Device Recall Prestige Plus Wire 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
    71537
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1845-2015
  • 사례 시작날짜
    2015-06-04
  • 사례 출판 날짜
    2015-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138150
  • 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
    During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture.
  • 조치
    Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.

Device

Device Recall Prestige Plus Wire
  • 모델명 / 제조번호(시리얼번호)
    Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution and one account in Canada.
  • 제품 설명
    Prestige Plus 185cm J-Tip: || Part number: 9185J; || Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
  • Manufacturer
    Volcano Corporation

Manufacturer

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