Events

Retiro De Equipo (Recall) de SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TERUMO BCT (CANADA) INC..

¿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
    50981
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-06-29
  • 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
    This notice is to inform you of a situation with the spectra optia system's return line air detector (rlad) that may have an impact on spectra optia procedures. the spectra optia system has experienced a low number of failures of the rlad that have resulted in a non-continuable alarm condition. this impacts all machines with software version 5 and higher. the software version is identified on the screen of the device upon power up. if air is detected falsely due to an rlad failure during a procedure a continuous "air detected in the return line" alarm will occur and will not allow the procedure to continue. if the rlad experiences a defect during prime the system will generate a "return line air detector failed fluid check" alarm and will not allow a procedure to be performed until serviced. no serious injury or death has been associated with these failures. we do not believe this is a disposables related issue.

Device

SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 61000 (Lot serial: All)
  • Descripción del producto
    Spectra Optia Apheresis System
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

TERUMO BCT (CANADA) INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    HC