Events

Device Recall Stockert S5 System I Sorin C5 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
    67199
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0856-2014
  • 사례 시작날짜
    2013-12-04
  • 사례 출판 날짜
    2014-01-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-12-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124941
  • 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 is initiating a field correction on s5/c5 heart-lung machine and cp5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
  • 조치
    Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.

Device

Device Recall Stockert S5 System I Sorin C5 System
  • 모델명 / 제조번호(시리얼번호)
    S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.
  • 제품 설명
    S5/C5 Heart-lung machine || Product Usage: The StOckert S5/ Sorin C5 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