Events

Recall of Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CELEO Pty Ltd.

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
    RC-2013-RN-00167-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00167-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During internal testing, the manufacturer vital images has found that an error can occur when images are rotated in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. this orientation adjustment has been found to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty nine percent and in volume measurements of up to fifty percent.
  • Action
    Vital Images recommends that all measurements associated with the issue are verified against results from other technologies. A software patch is under development to correct the issue.

Device

Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)
  • Model / Serial
    Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)All versions prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3ARTG Number: 142791
  • Product Classification
    Radiology Devices
  • Manufacturer
    CELEO Pty Ltd

Manufacturer

CELEO Pty Ltd
  • Source
    DHTGA