Events

Device Recall SK6000 PAQ drape pouch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NOVADAQ TECHNOLOGIES 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
    75006
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2767-2016
  • 사례 시작날짜
    2016-08-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149092
  • 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
    System, x-ray, angiographic - Product Code IZI
  • 원인
    Novadaq is informing sk6000 paq users that a pinhole through the drape pouch film material was identified in some sk6000 paqs during shipping validation testing.
  • 조치
    The firm, Novadaq, sent an "URGENT DEVICE CORRECTION: SK6000 PAQ Drape Pouch" letter dated 8/18/2016 to affected consignees. The Firm instructed consignee to cease distribution of affected product; accept the shipping-validated replacement PAQ; complete and sign the enclosed "Acknowledgment of Receipt" form, scan it and email to quality@novadaq.com. If you have any questions, contact Director of Regulatory Affairs at 1-905-629-3822 ext 205 or email: jpendlebury@novadaq.com. .

Device

Device Recall SK6000 PAQ drape pouch
  • 모델명 / 제조번호(시리얼번호)
    Lot # 16047 and 16046
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in states of: FL, MI, and VA.
  • 제품 설명
    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) || The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
  • Manufacturer
    NOVADAQ TECHNOLOGIES INC.

Manufacturer

NOVADAQ TECHNOLOGIES INC.
  • 제조사 주소
    NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA