Events

Recall of Device Recall Philips Healthcare Informatics iSite PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare Informatics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48986
  • Event Risk Class
    Class 2
  • Event Number
    Z-2346-2008
  • Event Initiated Date
    2008-07-03
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72453
  • Notes / Alerts
    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.
  • Extra notes in the data
    Picture Archiving and Communication System - Product Code LLZ
  • Reason
    Scout line and localizer crosshair on mpr images will display in the incorrect position under certain circumstances.
  • Action
    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
  • Model / Serial
    all products with software versions 3.5.x
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
  • Product Description
    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.
  • Manufacturer Address
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA