Events

Recall of Device Recall Philips IntelliSpace PACS 4.4 Image Management Systems

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
    68979
  • Event Risk Class
    Class 2
  • Event Number
    Z-2252-2014
  • Event Initiated Date
    2014-07-24
  • Event Date Posted
    2014-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129194
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    A problem was detected in the philips intellispace pac 4.4 software where if patient information is changed in the dicom header and the study is exported before the image is updated in the pacs, the unchanged data may export causing the potential for diagnosis on incomplete data.
  • Action
    Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.

Device

Device Recall Philips IntelliSpace PACS 4.4 Image Management Systems
  • Model / Serial
    IntelliSpace 4.4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
  • Product Description
    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and 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