Events

Retiro De Equipo (Recall) de Philips SENSE Body Coil 1.5T (used with ACS NT, Intera 1.5T, and Achieve 1.5T MR 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
    18767
  • Fecha de inicio del evento
    2015-07-03
  • 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 instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the quadrature body coil (qbc).
  • Acción
    Product to be modified

Device

Philips SENSE Body Coil 1.5T (used with ACS NT, Intera 1.5T, and Achieve 1.5T MR Systems)
  • Modelo / Serial
    Model: 4522 131 5575x, 4522 132 1985x. 4522 132 7619x, 4598 000 5187x, 4598 000 5189x, 4598 003 590511 (where x can be a number from 1 to 9), Affected: All lots
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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