Events

Retiro De Equipo (Recall) de Biograph Horizon with VJ20A Software

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2018-RN-00126-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-08
  • 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-2018-RN-00126-1
  • 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
    Siemens healthineers has become aware of an issue with the pet quality control software that introduces an error into the pet normalization file. as a result there may be minimal visual and quantitative impacts to the pet images acquired and reconstructed with petsyngo vj20a software.
  • Acción
    Siemens will be in contact with affected customers to arrange for a software update to be installed. In the event that users have any concerns about data that has been previously acquired and reconstructed prior to correction, users may refer to the Customer Letter for instructions for reconstructing data with a new normalization file.

Device

Biograph Horizon with VJ20A Software
  • Modelo / Serial
    Biograph Horizon with VJ20A SoftwareCatalogue Number: 10532746 and 10532748ARTG Number: 271560 (Siemens Healthcare Pty Ltd - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA