Retiro De Equipo (Recall) de Device Recall Mobilett Mira Mobile Xray

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, mobile - Product Code IZL
  • Causa
    Siemens issued a field safety alert about the potential risk to users when operating the mobilett mira. when a mobilett mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. this.
  • Acción
    Siemens sent a Field Safety Notice dated May 2. 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to : 1) Never step or sit on the unit or otherwise put substantial weight on it. 2) Avoid moving the unit over high thresholds for doors or elevators where possible, or do so carefully and slowly. 3) Make sure that no person had his/her extremities under the chassis, also when the unit is not moving. Update instructions were also released to alert customers of the potential risk and to provide a hardware change which is intended to improve corrosion resistance. An acknowledgement of receipt form was also sent out for the field safety notice and requested to be returned to Siemens. For further questions please call (888) 826-9702.


  • Modelo / Serial
    Model number 10273100
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
  • Descripción del producto
    Mobiletta Mira || Mobile X-ray System
  • Manufacturer


  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
  • Source