Events

Precedence SPECT/CT System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Phillips Nuclear Medicine 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
    45329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0676-2008
  • 사례 출판 날짜
    2008-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65274
  • 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
    Pulse Doppler Ultrasonic Imaging System - Product Code KPS
  • 원인
    Incorrect measurement: the firm discovered a software defect in cardiac and pulmonary viewer software application options used in the precedence ct sub-system. the defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.
  • 조치
    A Customer Advisory Notification was mailed to affected consignees on September 28, 2007. The firm informed consignees that incorrect measurement can occur when the Cardiac Viewer or Pulmonary Viewer is used to zoom and save derived images in batch files. The firm provided instructions for operators to prevent incorrect measurements. Phillips is currently investigating methods to correct this issue and will provide updates, free of charge, when they become available. If you have questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnostic Imaging, option 5:NM).

Device

Precedence SPECT/CT System
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 2169-3000A/453560250851;  2169-3001A/453560250861;  2169-3002A/453560253551; and  2169-3003A/453560253561
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.
  • 제품 설명
    Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
  • Manufacturer
    Phillips Nuclear Medicine

Manufacturer

Phillips Nuclear Medicine
  • 제조사 주소
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA