Events

Retiro De Equipo (Recall) de DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    65563
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-11-13
  • 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 recall is due to an update by ge healthcare on the preventative maintenance and cleaning procedures of the exposure switches footswitches and hand switches of x-ray systems to address aggressive disinfectant procedures used by the users. the updates include recommended replacement of console switches every three years and recommends cleaning x-ray systems with cloth moistened in warm soapy water or cleaners approved by ge.

Device

DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM
  • Modelo / Serial
    Model Catalog: S2000PA/PB (Lot serial: n/a); Model Catalog: S0910JB (Lot serial: n/a); Model Catalog: 5555000 (Lot serial: n/a); Model Catalog: 5555000-2 (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a); Model Catalog: 2275938-7 (Lot serial: n/a); Model Catalog: 2236420-7 (Lot serial: n/a); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 2169360-7 (Lot serial: n/a); Model Catalog: 46-270954G1 (Lot serial: n/a); Model Catalog: 46-270157G-1 (Lot serial: n/a); Model Catalog: 2115090-12 (Lot serial: n/a); Model Catalog: 2403791 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 2407576 (Lot serial: n/a); Model Catalog: 46-329267G1 (Lot serial: n/a); Model Catalog: 2115090 (Lot serial: n/a)
  • Descripción del producto
    DEFINUM AMX 700 DIGITAL MOBILE SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)