Events

Retiro De Equipo (Recall) de Cleveland CT

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
    22197
  • Fecha de inicio del evento
    2017-11-06
  • 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
    The manufacturer has become aware of a potential problem with our philips brilliance 64/ ingenuity family version 4.1.6 as detailed below:, issue 1: cardiac signal not found in workflow issue, issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start, issue 3: pulmo gates on cardiac workflow issue, issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well., issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results, issue 6: application may fail when modifying the results plan box during 3d calcium score, issue 7: tube too hot, issue 8: memory overflow issue, issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message, issue 10: issue with the generatormonitor state machine in rhost code issue.
  • Acción
    Manufacturer to issue advice regarding use

Device

Cleveland CT
  • Modelo / Serial
    Model: , Affected: The following CT(Computed Tomography) systems are affected: Brilliance 64 728231, Ingenuity Core128 728323, Ingenuity CT 728326, Software version: Running software version: 4.1.6
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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