Events

Retiro De Equipo (Recall) de Philips CDAS Intera MR Systems equiped with Basic Triggering Unit

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 Philips Medical Systems Nederland BV.

¿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
    18027
  • Fecha de inicio del evento
    2015-01-28
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Affected lithium polymer batteries may fail after being physically dropped from a height (i.E. from waist height to floor). the failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. the failure of the battery may occur instantly or may be delayed for a short period of time.
  • Acción
    Product to be exchanged

Device

Philips CDAS Intera MR Systems equiped with Basic Triggering Unit
  • Modelo / Serial
    Model: Part Number 9065 and 9067 Lithium Polymer Fiber Optic Module Batteries (for use with Philips Basic Triggering Set [452213224543], Monitoring Sensor Set [452213224623], Battery Set [452215033673] and Service Parts [453564099151]), Affected: All batteries with date codes 2808 or earlier
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA