Events

Device Recall "PHILIPS PLUS" COMPUTED TOMOGRAPHY 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
    52176
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1578-2009
  • 사례 시작날짜
    2009-02-19
  • 사례 출판 날짜
    2009-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82413
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    A software anomaly in the tumorloc software for the firm's brilliance ct scanners was discovered. the same software anomaly was subsequently determined to be present in the firm's gemini pet/ct units. the software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series id.
  • 조치
    An "URGENT - Field Safety Notice" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.

Device

Device Recall "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    GEMINI TF 16 Slice, Serial Numbers: 7035, 7052, 7093, 7096, 7123, 7128, and 7133; GEMINI TF 16 Slice base configuration, Serial Number: 7150; and GEMINI TF 64 Slice, Serial Numbers: 7007, 7088, 7103, 7126, and 7132.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.
  • 제품 설명
    TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration. || Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.
  • 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