Devices

Device Recall iSite PACS

  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.
  • Product Description
    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

Manufacturer

Philips Healthcare Informatics, Inc.
  • Manufacturer Address
    Philips Healthcare Informatics, Inc., 4100 East Third Avenue, Suite 101, Foster City CA 94404
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

Device Recall ISite PACS
  • Model / Serial
    All models, version 3.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
  • Manufacturer
    Stentor Inc
Device Recall iSite PACS
  • Model / Serial
    Version 3.5
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
  • Product Description
    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
  • Model / Serial
    Version number 3.6.28.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
  • Product Description
    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
  • Model / Serial
    Version 4.1.17.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
  • Product Description
    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.
  • Model / Serial
    Software versions 3.6.28.x and 4.1.x.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
  • Product Description
    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.
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