Events

Retiro De Equipo (Recall) de Gebruder Martin ML 301 Examination Lamp

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 Gebruder Martin GmbH & Co KG.

¿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
    14398
  • Fecha de inicio del evento
    2013-04-11
  • 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: Ortho Medics Limited, 586 Great South Road, Ellerslie, Auckland 1051
  • Causa
    There are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. the manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. if the joint breaks, the spring arm falls suddenly and wthout hindrance. in such a case there is a high risk of injury to the patient and other persons in the immediate vicinity.
  • Acción
    Product to be returned to supplier

Device

Gebruder Martin ML 301 Examination Lamp

Manufacturer

Gebruder Martin GmbH & Co KG