Events

Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    68643
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2037-2014
  • 사례 시작날짜
    2014-06-18
  • 사례 출판 날짜
    2014-07-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128391
  • 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
    System, tomography, computed, emission - Product Code KPS
  • 원인
    When beginning a procedure to start the gantry and ct host, a close estop message may appear to the operator, but disappears before action can be taken. if this occurs it results in an inability to close e-stop and the system is not operational for clinical use. this problem occurs randomly.
  • 조치
    Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update.

Device

Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore
  • 모델명 / 제조번호(시리얼번호)
    GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M  GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606  GEMINI TF Big Bore: 882476 9019,9227,9232,9233
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CA, CO, IL, OK, OR and WI.
  • 제품 설명
    GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA