Events

Retiro De Equipo (Recall) de Device Recall Artis zeego

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
    80286
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2314-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165059
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
  • Acción
    On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed. The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.

Device

Device Recall Artis zeego
  • Modelo / Serial
    160851 160869 160943 160817 160852 160834 160972 160463 160944 160406 160913 160877 160488 160800 160884 160823 160916 160814 160872 160905 160915 160447 160481 160501 160874 160862 160860 160878 160957 160412 160856 160387 160432 160903 160917 160889 160813 160461 160912 160919 160838 160507 160487 160825 160850 160430 160801 160323 160498 160509 161004 160896 160894 160830 160519 160469
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Artis zeego, Material no. 10280959 || , for angiography and whole body radiographic/fluoroscopic procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA