Devices

Device Recall iSite PACS

  • 모델명 / 제조번호(시리얼번호)
    iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and  3.5.65.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.
  • 제품 설명
    iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
  • Manufacturer
    Philips Healthcare Informatics, Inc.
  • 1 Event

제조사

Philips Healthcare Informatics, Inc.
  • 제조사 주소
    Philips Healthcare Informatics, Inc., 4100 East Third Avenue, Suite 101, Foster City CA 94404
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall ISite PACS
  • 모델명 / 제조번호(시리얼번호)
    All models, version 3.3
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • 제품 설명
    iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
  • Manufacturer
    Stentor Inc
Device Recall iSite PACS
  • 모델명 / 제조번호(시리얼번호)
    Version 3.5
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
  • 제품 설명
    The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment.
  • Manufacturer
    Stentor Inc A Phillips Medical Systems Co.
Device Recall iSite PACS
  • 모델명 / 제조번호(시리얼번호)
    Version number 3.6.28.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
  • 제품 설명
    Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
  • Manufacturer
    Philips Healthcare Informatics, Inc.
Device Recall iSite PACS
  • 모델명 / 제조번호(시리얼번호)
    Version 4.1.17.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
  • 제품 설명
    Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
  • Manufacturer
    Philips Healthcare Informatics, Inc.
Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.
  • 모델명 / 제조번호(시리얼번호)
    Software versions 3.6.28.x and 4.1.x.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
  • 제품 설명
    iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. || The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
  • Manufacturer
    Philips Healthcare Informatics, Inc.
하나 더 3 건 더