Events

Retiro De Equipo (Recall) de INGENUITY 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
    130773
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-17
  • 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 of the following issues: - slab viewer longitudinal location issue - it is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur: -the patient is placed in a "feet-first" orientation. -an interventional ct procedure is scheduled. -contrary to typical clinical practice a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr). -a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure). -the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location). - fast get ready issue - fast get ready incorrectly enabled during service procedures. - contrast annotation issue - contrast annotation incorrectly missing for some images when manual contrast was administered. - dot artifact issue - dot artifact present intermittently after startup. - heart rate update issue - heart rate measured value incorrectly remains constant for some heart rate change conditions. - doseright issue - doseright incorrectly enabled when the exam card specified disabling doseright. - tube heat issue - tube heat predictor fails to warn of overheat condition for long scans.

Device

INGENUITY CT SYSTEM
  • Modelo / Serial
    Model Catalog: 728326 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL)
  • Descripción del producto
    INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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