Events

Retiro De Equipo (Recall) de MX8000 IDT MULTISLICE C+ IMAGING 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
    26539
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-07-15
  • 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 the affected 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 3 mm 4 mm 5mm 6 mm 7 mm and 8 mm 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 instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable. the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.

Device

MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Modelo / Serial
    Model Catalog: OFF-EI-590 (Lot serial: ); Model Catalog: 362299 (Lot serial: ); Model Catalog: 4535 670 73191 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 73181 (Lot serial: N/A FOR ALL)
  • Descripción del producto
    MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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