Events

Retiro De Equipo (Recall) de CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)

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-2015-RN-00073-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-29
  • 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-00073-1
  • 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 pty ltd has received a report that the column of a cs 8100 demonstration device descended unexpectedly as one of the two retaining clips (circlips) that holds the locating pin in place was missing. if a circlip is not placed on both ends of the locating pin, it is possible that movement and transport of a unit can cause the pin to move out of position, or fall out completely. testing showed the device operation could appear normal for several lifting cycles after the pin fell out completely due to friction holding the ends of two units together, but the jack would eventually slip off the base plate stand. no other reports, complaints or injuries of this type (related to missing circlip) have been received since the device was introduced into commercial distribution in 2012.
  • Acción
    Carestream Health Australia is organising a service call and a service engineer will attend the user’s site, make a detailed inspection and replace the column assembly if required. This action has been closed-out on 24/05/2016.

Device

CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)
  • Modelo / Serial
    CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)Serial numbers starting WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD.Manufacturing Date: June 2012 to September 2014ARTG Number: 136114 and 136106
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd