Events

Recall of GE Centricity Web

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
    64762
  • Event Risk Class
    Class 2
  • Event Number
    Z-0454-2014
  • Event Initiated Date
    2012-04-19
  • Event Date Posted
    2013-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117060
  • 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
    Digital Image Communications Radiological System - Product Code LMD
  • Reason
    Ge healthcare has become aware of an issue associated with rejected images using the wado protocol within ge centricity web that may impact patient safety. the wado (web access to dicom objects) interface allows for embedding dicom images as jpegs on a web page and is available as a licensed operation on centricity web. when rejected images are archived by centricity pacs to enterprise archive, an.
  • Action
    Urgent Medical Device Correction letters dated April 19, 2013 were sent to customers. The letter requests that customers ensure that their system is configured to disable the WADO interface using the included instructions until the software revision can be installed at their site. The letter further informs customers that updated software will be sent to them for installation.The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI# 85206R.

Device

GE Centricity Web
  • Model / Serial
    Software versions: 3.0.x
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.
  • Product Description
    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.
  • 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