Events

Retiro De Equipo (Recall) de TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Inovanz Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01358-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01358-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / 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