Events

GEMINI TF 16 PET/CT Xray Diagnostic Imaging System 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
    60302
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0343-2012
  • 사례 시작날짜
    2011-04-25
  • 사례 출판 날짜
    2011-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104992
  • 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
    In response to complaints received by philips medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their gemini pet/ct x-ray system units in the field. the firm believes that if these software defects were to recur, it could impact the performance of reliability of the these pet/ct system units.
  • 조치
    Philips Healthcare sent a "CPE CUSTOMER LETTER" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.

Device

GEMINI TF 16 PET/CT Xray Diagnostic Imaging System
  • 모델명 / 제조번호(시리얼번호)
    The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473, Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.
  • 제품 설명
    Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. || The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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