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
    46414
  • Event Risk Class
    Class 2
  • Event Number
    Z-1141-2008
  • Event Initiated Date
    2008-01-04
  • Event Date Posted
    2008-05-08
  • 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=67399
  • 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
    patient image management system - Product Code LLZ
  • Reason
    Incorrect display of one of the patient's images. this malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. the original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
  • Action
    Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.

Device

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.

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