Events

Retiro De Equipo (Recall) de Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2015-RN-01104-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-13
  • 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-2015-RN-01104-1
  • 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 discovered through customer complaints and internal testing that there is an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. no injuries attributed to the problem have been reported.
  • Acción
    The sponsor will perform a software update to the affected devices. In the meantime, the user is advised to always observe real time dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. This action has been closed-out on 05/12/2016.

Device

Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x o...
  • Modelo / Serial
    Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16Product Codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059, 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023.Allura Xper FD R2.xProduct Code: 722006Allura Xper FD R8.2.0 Product Code: 722035ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA