Events

Recall of TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Inovanz 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-2016-RN-01358-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01358-1
  • 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
    It has been identified that the frax adjusted for tbs values are not correct when the frax feature is activated in tbs insight and tbs has been computed from a spine scan where some vertebrae were excluded. this does not affect the trabecular bone scores. patient fracture risk evaluations could be altered based on this issue.
  • Action
    Inovanz has advised users of a new software version, v.3.0.2, that is available and incorporates a permanent fix for this issue. In the interim, Inovanz has advised users to immediately deactivate the FRAX adjusted for TBS feature. In addition, a tool is being provided that will automatically analyse and provide a detailed report for all erroneous fracture risk evaluations with v.3.0.1. This action has been closed-out on 24/05/2017.

Device

TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)
  • Model / Serial
    TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)ARTG Number: 227987
  • Manufacturer
    Inovanz Pty Ltd

Manufacturer

Inovanz Pty Ltd
  • Source
    DHTGA