Events

Recall of Device Recall GE Centricity Web Diagnostic (WebDx)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Medical Systems Information T.

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
    64545
  • Event Risk Class
    Class 2
  • Event Number
    Z-1782-2017
  • Event Initiated Date
    2013-02-18
  • Event Date Posted
    2017-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116455
  • 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
    It was reported from a complaint that study category labels of "prior" and "baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
  • Action
    Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.

Device

Device Recall GE Centricity Web Diagnostic (WebDx)
  • Model / Serial
    Versions 1.0, 1.1, 2.0, 2.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Worldwide
  • Product Description
    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
  • Manufacturer
    Ge Medical Systems Information T

Manufacturer

Ge Medical Systems Information T
  • Manufacturer Address
    Ge Medical Systems Information T, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA