Events

Retiro De Equipo (Recall) de ESSENTA DR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    151029
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-12-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware that 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 dismantied. if after reassembly of the system the lossened thread inserts become detached from the casting the c-arm would no longer be securely held in position and could fall. the c-arm is most often dismantied and reassembled when the system is moved to another location.

Device

ESSENTA DR
  • Modelo / Serial
    Model Catalog: 9890 010 87381 (Lot serial: 458280/SN10000031); Model Catalog: 9890 010 87381 (Lot serial: 433527/SN09000054); Model Catalog: 9890 010 87381 (Lot serial: 481201/SN11000021); Model Catalog: 9890 010 87381 (Lot serial: 423573/SN09000014); Model Catalog: 9890 010 87381 (Lot serial: 376657/SN08000030); Model Catalog: 9890 010 87381 (Lot serial: 396940/SN08000073); Model Catalog: 9890 010 87381 (Lot serial: 397186/SN08000042)
  • Descripción del producto
    ESSENTA DR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC