Recall of Device Recall iSite PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stentor Inc A Phillips Medical Systems Co..

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Image Processing System-Radiological - Product Code LLZ
  • Reason
    A defect may cause patient image orientation markers to be incorrectly labeled on multi-planar reformation (mpr) images. left and right anatomical orientation markers may be reversed.
  • Action
    The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.


  • Model / Serial
    Version 3.5
  • Product Classification
  • Device Class
  • Implanted device?
  • 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


  • Manufacturer Address
    Stentor Inc A Phillips Medical Systems Co., 4100 East Third Ave Suite 101, Foster City CA 94404
  • Source