Events

Recall of CENTRICITY UNIVERSAL VIEWER - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GE HEALTHCARE CANADA 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
    130524
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The following issue is being addressed by ge healthcare file no. fmi 85442. ge healthcare has recently become aware that a database handling error could occur during the image acquisition process affecting the completeness of acquired images with centricity universal viewer running on a pacs-iw foundation. there is a potential that one or more "image series" (i.E. all images within an image set) may be missing from an exam without a user warning displayed in the viewer. while this is rare this can occur with imaging studies that consist of a very small number of images per series. e.G. cr thorax exam with 1 image per series. there have been no injuries reported as a result of this issue.

Device

CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Model / Serial
    Model Catalog: 2088034-X (Lot serial: GTIN 00840682103800)
  • Product Description
    CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.