Events

Retiro De Equipo (Recall) de Philips iCT and iCT SP CT 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 (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
    13192
  • Fecha de inicio del evento
    2012-07-20
  • 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 the ct systems above, sixteen bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off., a risk of serious injury (bone fracture, head injury, concussion) was identified in the event that all sixteen (16) bolts are broken. if this occurs, and the carbon table top is extended, the table top may tilt or tip over, or it may result in unintended pivotal motion of the table. if the patient is not secured to the table, there is a possibility the patient may slide off, which may cause serious injury. if less than sixteen (16) of the j-bracket bolts fail, the carbon table top will remain attached to the couch subframe.
  • Acción
    Product to be modified

Device

Philips iCT and iCT SP CT systems

Manufacturer

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