Events

Device Recall LATITUDE Patient Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 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
    57744
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2052-2011
  • 사례 시작날짜
    2011-01-10
  • 사례 출판 날짜
    2011-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97300
  • 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
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • 원인
    Boston scientific has determined that data within certain printed reports obtained from the latitude patient management system may not be accurate, in that, the most recent presenting electrogram (mrp-egm) for some of the selected patients may be either missing or incorrect.
  • 조치
    Consignees were sent a Boston Scientific "LATITUDE¿ Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.

Device

Device Recall LATITUDE Patient Management System
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 6.x versions launched on June 6, 2010 or later.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
  • 제품 설명
    Boston Scientific's LATITUDE Patient Management System: || LATITUDE 6.1 Patient Management System Website || Server software, Model 6488 for United States || Server software, Model 6465 for European Union || LATITUDE 6.2 Patient Management System Website || Server software, Model 6441 for Canada || Server software, Model 6442 for Australia / New Zealand || Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA