Events

Device Recall S5 Control Panel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group USA, Inc. 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
    61208
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1153-2012
  • 사례 시작날짜
    2012-02-16
  • 사례 출판 날짜
    2012-03-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107569
  • 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
    Touch screen may be unresponsive, inhibiting user input.
  • 조치
    All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.

Device

Device Recall S5 Control Panel
  • 모델명 / 제조번호(시리얼번호)
    Item number: 28-95-85; Serial numbers 50E65207 to 50E65212.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong Kong, Indonesia, Iraq, Iran, Israel, Italy, Japan, Jordan, Canada, British Columbia, South Korea, Kuwait, La Reunion, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Morocco, Mexico, Monaco, New Zealand, Netherlands, Norway, Oman, Austria, Phillippines, Poland, Portugal, Puerto Rico, Qatar, Serbia, Russia, Saudi Arabia, Sweden, Switzerland, Singapore, Spain, South Africa, Syria, Thailand, Czechoslavakia, Tunisia, Turkey, Hungary, Vietnam, and the United Arab Ermirates
  • 제품 설명
    S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA || The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA