Events

Device Recall MPS and MPS 2 Consoles 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Quest Medical, 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
    57141
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1924-2011
  • 사례 시작날짜
    2010-07-29
  • 사례 출판 날짜
    2011-04-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95458
  • 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
    Heat-exchanger, cardiopulmonary bypass. - Product Code DTR
  • 원인
    User update regarding installation of external heater-cooler units with mps and mps2 consoles.
  • 조치
    Quest Medical Incorporated sent a "User Update" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.

Device

Device Recall MPS and MPS 2 Consoles
  • 모델명 / 제조번호(시리얼번호)
    MPS Serial Numbers: 2022, 2023, 2024, 2297, 2307, 2177, 2258, 2259, 2261, 2263, 2266, 2421, 2422, 1198, 1379, 1385, 1395, 2022, 2023, 2024, 2335, 2336, 2396, 9069, 1407, 1408, 1409, and 2078
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
  • 제품 설명
    Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
  • Manufacturer
    Quest Medical, Inc

Manufacturer

Quest Medical, Inc
  • 제조사 주소
    Quest Medical, Inc, 1 Allentown Pkwy, Allen TX 75002-4206
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA