Events

Retiro De Equipo (Recall) de DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carestream Health Australia 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-2013-RN-00970-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-13
  • 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-2013-RN-00970-1
  • 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
    Carestream health australia has received reports from overseas of unusable diagnostic images on exams where a normal exposure mode (nem) view is exposed immediately prior to an extended exposure mode (eem) view with the system in fast preview mode.
  • Acción
    Carestream Health Australia is providing a firmware update that will allow NEM and EEM images to be taken in any order. The update will be provided at the next scheduled service or within 3 months. Until the firmware upgrade is installed end users are advised to only perform the EEM acquisition prior to the NEM acquisition.

Device

DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems
  • Modelo / Serial
    DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray SystemsAll lot numbers affectedARTG Numbers: 194055 & 161988
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd