Events

Recall of CENTRICITY PACS WORKSTATION - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    53907
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-28
  • 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
    In a reject image workflow where multiple studies are simultaenously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study images from the previously displayed study may also be rejected. the issue can occur with a previously displayed study that remains open in the background.

Device

CENTRICITY PACS WORKSTATION - SOFTWARE
  • Model / Serial
    Model Catalog: K2000YW (Lot serial: >10 numbers contact mfg)
  • Product Description
    Centricity PACS Workstation Software
  • Manufacturer
    GE HEALTHCARE

Manufacturer

GE HEALTHCARE