Events

Retiro De Equipo (Recall) de Philips HeartStart XL+ Defibrillator

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 (USA).

¿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
    18773
  • Fecha de inicio del evento
    2015-07-06
  • 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
    Philips has identifed the following xl+ software and hardware issues:, , software:, * the xl+ may fail to complete the power on sequence and continuously reboot., * the xl+ may either fail to power up or may shut down unexpectedly., * the xl+ may have a software version that did not reset a fail-safe monitoring component which could cause a delay of therapy or pacing interruption., * the xl+ may fail to generate verbal prompts in aed mode., , hardware:, * the speaker may fail., * the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery., * the xl+ exceeds the allowable radiated emissions level for class b cispr11., * the xl+ ecg signal from leads could be lost and unrecoverable., * the xl+ spo2 signal may lose communication and cause the device to reboot., * the xl+ battery detection system may be disrupted and cause a false low battery alarm.
  • Acción
    Product to be modified

Device

Philips HeartStart XL+ Defibrillator
  • Modelo / Serial
    Model: 861290, Affected: Serial number ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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