Events

Retiro De Equipo (Recall) de Philips Allura Xper FD and Allura Clarity x-ray systems

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
    19424
  • Fecha de inicio del evento
    2015-11-23
  • 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
    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1.C. no injuries attributed to the problem are reported.
  • Acción
    Software to be upgraded

Device

Philips Allura Xper FD and Allura Clarity x-ray systems
  • Modelo / Serial
    Model: 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023, 722026, 722028, 722035, 722058, Affected: , Software version: All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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