Retiro De Equipo (Recall) de Depuy Synthes Universal Battery Charger II (UBC II)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The ubc ii has a component which may fail prematurely due to a manufacturing defect. if the component fails, the charger’s firmware recognises 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. when component failure occurs, the device firmware causes the ubc ii to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay.
  • Acción
    JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.