Events

Retiro De Equipo (Recall) de Philips Angiographic X-Ray

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
    21265
  • Fecha de inicio del evento
    2017-03-29
  • 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
    Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire.
  • Acción
    Product to be modified

Device

Philips Angiographic X-Ray
  • Modelo / Serial
    Model: , Affected: Allura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chiller, Allura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chiller
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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