Events

Retiro De Equipo (Recall) de DePuy Universal Battery Charger

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 Synthes GmbH.

¿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
    19751
  • Fecha de inicio del evento
    2016-02-12
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Causa
    The ubc 11 with affected lot numbers has a component which may fail prematurely due to a manufacturing defect. if the component fails the charger's firmware recognizes the malfunction and prevents batteries from being charged. the blue led on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the user's manual.
  • Acción
    Product to be returned to supplier

Device

DePuy Universal Battery Charger
  • Modelo / Serial
    Model: 05.001.204, Affected: Lot Nos between 10615 and 12616
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH