Events

Recall of GE Healthcare Centricity Universal Viewer Version

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

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
    72472
  • Event Risk Class
    Class 2
  • Event Number
    Z-0226-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141166
  • 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
    Inaccurate distance measurements with magnified projection x-ray images.
  • Action
    An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images. GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. Attention should be given to prior cases acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue. GE Healthcare will correct all affected systems by providing a software update at no cost to the customer. GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Device

GE Healthcare Centricity Universal Viewer Version
  • Model / Serial
    2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
  • Manufacturer
    GE Healthcare

Manufacturer

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