Events

Sorin S5 Perfusionn System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group Deutschland GmbH 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
    66464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0142-2014
  • 사례 출판 날짜
    2013-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122435
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    Sorin group is recalling certain models of s5 perfusion systems due to malfunction of cardioplegia control.
  • 조치
    Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.

Device

Sorin S5 Perfusionn System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
  • 제품 설명
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. || The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH
  • 제조사 주소
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA