Events

Retiro De Equipo (Recall) de OPTIMA XR200AMX X-RAY 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 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
    27252
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-10-10
  • 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
    There is a potential for the system to have a technique accuracy issue which is greater than the 10% specified per the product documentation. if the user rapidly increases or decreases the mas or kv on the display the technique displayed may be one renard step off or one kv increment off from what the actual exposure delivered will be. this will only occur if the technique is adjusted more than three selections. if the user adjusts the techniques again after this rapid selection prior to exposure the display of the techniques and the actual delivered technique will be the same. these situations are not compliant with iec 60601-2-54 clause 203.6.4.3.104.6.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 5555000-4 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-3 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-6 (Lot serial: 00001027061WK9); Model Catalog: 5555000-5 (Lot serial: 00001027300WK1); Model Catalog: 5555000-5 (Lot serial: 00001027061WK9); Model Catalog: 5555000-6 (Lot serial: 00001028024WK6); Model Catalog: 5555000-5 (Lot serial: 00001028024WK6); Model Catalog: 5555000-6 (Lot serial: 00001027195WK5); Model Catalog: 5555000-5 (Lot serial: 00001027195WK5); Model Catalog: 5555000-6 (Lot serial: 00001027893WK5); Model Catalog: 5555000-5 (Lot serial: 00001027893WK5); Model Catalog: 5555000-6 (Lot serial: 00001027826WK5); Model Catalog: 5555000-5 (Lot serial: 00001027826WK5); Model Catalog: 5555000-6 (Lot serial: 00001027346WK4); Model Catalog: 5555000-5 (Lot serial: 00001027346WK4); Model Catalog: 5555000-6 (Lot serial: 00001027263WK1); Model Catalog: 5555000-5 (Lot serial: 00001027263WK1); Model Catalog: 5555000-6 (Lot serial: 00001027300WK1); Model
  • Descripción del producto
    OPTIMA XR200AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)