Events

Recall of Device Recall GE Centricity Web Diagnostic 1.0(WebDX) Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare It.

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
    55040
  • Event Risk Class
    Class 2
  • Event Number
    Z-1395-2010
  • Event Initiated Date
    2010-02-18
  • Event Date Posted
    2010-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89733
  • 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
    There is a potential safety issue associated with the use of ge centricity pacs-iw and pacs web diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.
  • Action
    An "Urgent Medical Device Correction" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.

Device

Device Recall GE Centricity Web Diagnostic 1.0(WebDX) Software
  • Model / Serial
    Software version 3.7.7.x
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Manufacturer Address
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA