Events

Retiro De Equipo (Recall) de Kodak 2100 and 2200 Intraoral X-ray System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Carestream Health Inc.

¿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
    16227
  • Fecha de inicio del evento
    2014-02-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • Causa
    The manufacturer advises that it 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
    Product to be modified

Device

Kodak 2100 and 2200 Intraoral X-ray System
  • Modelo / Serial
    Model: Kodak 2100 & 2200 Intraoral X-Ray System, Affected: Manufactured in China between May 2008 and April 2010
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    NZMMDSA