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 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
    46942
  • Event Risk Class
    Class 2
  • Event Number
    Z-1444-2008
  • Event Initiated Date
    2008-01-29
  • Event Date Posted
    2008-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69033
  • 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 Management System - Product Code LLZ
  • Reason
    When using the freehand region of interest (roi) tool, errors may occur in area calculation yielding incorrect results. the firm discovered that a descrepancy exists in the measurement provided by the tool.
  • Action
    The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.

Device

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.

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