Events

Retiro De Equipo (Recall) de FerriScan (software for determining liver iron concentration from MRI images)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Resonance Health Analysis Services 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-01233-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-09-20
  • 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-01233-1
  • 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 there is a misprint in the liver iron concentration (lic) measurement units on a subset of ferriscan reports. the report should include the average liver iron concentration result in mg/g dry tissue on the first line of the report and in mmol/kg dry tissue on the second line. this misprint only affects the second line result, where mg/g dry tissue is displayed rather than the correct units of mmol/kg dry tissue. the correct value (number) is displayed. the first line has both the correct value (number) and correct measurement units. an investigation by resonance health determined that the misprint only occurred in specified reports where the lic value was greater than 43 mg/g of dry tissue. as such, the misprint for the second line result only occurs in cases of extreme liver iron overload. no other reports are affected.
  • Acción
    Resonance Health is advising those with affected reports of the error in the measurement units and will re-issue reports on the request of users. This action has been closed-out on 10/05/2017.

Device

FerriScan (software for determining liver iron concentration from MRI images)
  • Modelo / Serial
    FerriScan (software for determining liver iron concentration from MRI images)Reports with LIC > 43 mg/g of dry tissue and issued between 5 Oct 2105 to 26 Aug 2016ARTG Number: 116071
  • Manufacturer
    Resonance Health Analysis Services Pty Ltd

Manufacturer

Resonance Health Analysis Services Pty Ltd