Events

Retiro De Equipo (Recall) de VMX MOBILE X-RAY 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
    63322
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-16
  • 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
    Ge healthcare has become aware of an issue associated with the base casting for the articulated arm of the vmx and vmx plus mobile x-ray systems that may impact operator or patient safety. the casting which retains the articulated arm to the base of the vmx may develop fatigue cracks through long term use of the product. if the casting develops cracks of significant size the articulated arm may no longer be properly secured to the base of the vmx. the loss of retention may permit the articulated arm x-ray tube and collimator to fall in an uncontrolled manner. the fall of this object may create a hazard to operators and patients during transport or use of the equipment.

Device

VMX MOBILE X-RAY SYSTEM
  • Modelo / Serial
    Model Catalog: 45296477 (Lot serial: All); Model Catalog: S20201SD (Lot serial: All); Model Catalog: 45296350 (Lot serial: All)
  • Descripción del producto
    VMX Mobile X-ray System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)