Retiro De Equipo (Recall) de Device Recall Siemens

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
    Table, radiographic, non-tilting, powered - Product Code IZZ
  • Causa
    There is a potential issue and possible hazard to patients when using the axiom vertix md trauma systems. in rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the u-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.
  • Acción
    Siemens sent a Safety Advisory Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised as a first check it is strongly recommended for the users to check whether metallic dust or rubbed off parts of metal are visible underneath the lifting column or around the system. If this is the case, it is strongly recommended to immediately stop using the Vertix MD Trauma system and call the local Siemens service. To avoid any risk until the implementation of the modification mentioned below, it is furthermore strongly recommended to perform up/down movements of the lifting column not directly above the patient, but complete the vertical movement beside the patient and then move the system horizontally above the patient. We appreciate your understanding and cooperation with this Safety Advisory Notice and ask you to immediately instruct your personnel accordingly. Please ensure that this Safety Advisory Notice is placed in the system's instructions for use until the update has been installed. If you have sold or otherwise disposed of this equipment and it is no under your control, we kindly ask that you forward this Safety Advisory Notice to the new user of the equipment. Please also inform us about the new owner of the equipment. We apologize for any inconvenience this may cause. Further questions please call (610) 219-6300.


  • Modelo / Serial
    AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution including MO and OH.
  • Descripción del producto
    AXIOM Vertix MD Trauma systems || radiographic X-ray
  • Manufacturer


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