Events

Retiro De Equipo (Recall) de BRILLIANCE 6/10/16 SLICE CT SYSTEM

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
    130152
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-21
  • 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
    The ct system phantom supplied with certain scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm 4mm 5mm 6mm 7mm and 8mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the ifu manual. however the pin visibility deteriorates over time usually a few years. this causes the test to become unreliable and inaccurate. to ensure that low contrast is within specification philips is providing instructions as a guideline to a more reliable check of the image noise on the water layer of the system phantom.

Device

BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Modelo / Serial
    Model Catalog: 4535 670 73181 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 73191 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 00121 (Lot serial: ); Model Catalog: OFF-EI-590 (Lot serial: )
  • Descripción del producto
    BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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