Events

Device Recall Latitude Patient Management System Communicator 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
    61390
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1445-2012
  • 사례 시작날짜
    2012-02-24
  • 사례 출판 날짜
    2012-04-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107985
  • 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 latitude¿ patient management system communicators were shipped to the incorrect patients.
  • 조치
    The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268.

Device

Device Recall Latitude Patient Management System Communicator
  • 모델명 / 제조번호(시리얼번호)
    219329 218900 219316 219304 219367 219372 218958 218842
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.
  • 제품 설명
    Boston Scientific LATITUDE¿ Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or 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