Events

Retiro De Equipo (Recall) de Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)

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-2018-RN-00233-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-15
  • 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-00233-1
  • 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
    Philips has identified that there may be an issue with acquisition if the addonics mass storage device (msd) provided with the system is connected to the console and powered on during an acquisition.Following a period of inactivity, the addonics msd may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding resulting in a potential re-scan being required.
  • Acción
    Philips is advising users to not view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Philips will be providing an updated Mass Storage Device to all affected customer to correct the issue.

Device

Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)
  • Modelo / Serial
    Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)PET/CT System Model Number: 882442MSD Serial Number: 2090ARTG Number: 292543(Philips Electronics Australia - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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