Events

Retiro De Equipo (Recall) de AXIOM ARISTOS FX

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
    Recall
  • ID del evento
    71029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1583-2015
  • Fecha de inicio del evento
    2015-04-14
  • Fecha de publicación del evento
    2015-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135880
  • 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, stationary - Product Code KPR
  • Causa
    If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
  • Acción
    The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.

Device

AXIOM ARISTOS FX
  • Modelo / Serial
    Model Number of device: 7414803, Serial #s:  1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA