Events

Retiro De Equipo (Recall) de Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)

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-2014-RN-00142-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-10
  • 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-2014-RN-00142-1
  • 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 advice that there were five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°.The failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. should the arm fall, there is a risk of injury by impact to the patient or user.
  • Acción
    To address this issue, a service engineer will attend the customer site, make a detailed inspection and install a bracket modification/replacement kit to address the problem. In the interim, customers are recommended to undertake regular inspections of their units to ensure that the arm has not failed. This action has been closed-out on 01/02/2016.

Device

Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)
  • Modelo / Serial
    Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)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.ARTG inclusion number: 136106
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd