Events

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
    Recall
  • Event ID
    37479
  • Event Risk Class
    Class 2
  • Event Number
    Z-0616-2007
  • Event Initiated Date
    2007-02-14
  • Event Date Posted
    2007-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50606
  • 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.

Device

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.

Manufacturer

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