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

¿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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    A single occurrence of a cross wired appliance connector within a carestream drx-1 system console was discovered during system testing prior to shipment. carestream has determined that a field inspection is necessary to ensure there are no consoles in the field with the cross wiring configuration. if a cross wired console is in use under the combination of circumstances where a facility does not have an intact electrical ground an operator or service person is touching the console and another grounded surface there could be a risk of severe electrical shock. this type of event is very unlikely as all of these circumstances must be true in order for the hazard to manifest.


  • Modelo / Serial
    Model Catalog: 827 8186 (Lot serial: >10 numbers contact mfg); Model Catalog: 116 8079 (Lot serial: 181); Model Catalog: 8011199 (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    Carestream DRX-1 System
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source