Events

Device Recall Philips Healthcare Informatics iSite PACS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare Informatics, 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
    48986
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2346-2008
  • 사례 시작날짜
    2008-07-03
  • 사례 출판 날짜
    2008-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72453
  • 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
    Picture Archiving and Communication System - Product Code LLZ
  • 원인
    Scout line and localizer crosshair on mpr images will display in the incorrect position under certain circumstances.
  • 조치
    A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.

Device

Device Recall Philips Healthcare Informatics iSite PACS
  • 모델명 / 제조번호(시리얼번호)
    all products with software versions 3.5.x
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
  • 제품 설명
    Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x || The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • 제조사 주소
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA