Events

Retiro De Equipo (Recall) de UROSKOP OMNIA

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

¿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
    48072
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-08-28
  • 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
    1.) during a rad examination with automatic exposure control a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality resulting in the examination needing to be repeated. statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode. the automatic exposure control is used less frequently with the uroskop omnia therefore reducing the risk that such malfunction might occur. 2.) when selecting a tomo ogp in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own. 3.) sporadically it may occur that the radiation is not activated and therefore an exposure is performed without radiation. in case of a scan sequence at luminos drf the complete sequence might have to be repeated.

Device

UROSKOP OMNIA
  • Modelo / Serial
    Model Catalog: 10094910 (Lot serial: S/N 3071); Model Catalog: 10094200 (Lot serial: 16 UNITS CONTACT MFR FOR S/N)
  • Descripción del producto
    UROSKOP OMNIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC