Events

Device Recall Medtronic Paceart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Managment 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
    39422
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0081-2008
  • 사례 시작날짜
    2007-08-27
  • 사례 출판 날짜
    2007-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55510
  • 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
    trans-telephonic pacemaker evaluation system - Product Code DPS
  • 원인
    An issue with the paceart system - 2006 first edition (get connected edition) exists. under certain circumstances, paceart system generic icd reports may not accurately reflect patient vt/vf, svt/nst and mode switch/at/af episode detection data. when episode detection data is imported into the paceart system from certain sources, the paceart system generic icd reports display a zero, suggesting.
  • 조치
    A Medtronic letter was sent to consignees on 8/27/07. The letter described the issue and the product involved. It also notified customers that Medtronic is developing a software update that will correct the issue. An Acknowledgement form was attached to be filled by consignees as confirmation and understanding of the information received.

Device

Device Recall Medtronic Paceart
  • 모델명 / 제조번호(시리얼번호)
    Paceart System - 2006 First Edition (Get Connected Edition)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Source
    USFDA