Retiro De Equipo (Recall) de Philips Essenta DR Digital X-Ray, C-arm

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 DMC GmbH.

¿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
    15878
  • Fecha de inicio del evento
    2013-12-17
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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
    If during system installation, the screws holding the c-arm were mounted using thread locking compound (e.G. loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if, after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
  • Acción
    Product to be modified

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA