Events

Retiro De Equipo (Recall) de Device Recall Syngo RT Therapist, Accelerator, Linear, Medical

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
    75113
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2878-2016
  • Fecha de inicio del evento
    2016-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149417
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Software patch installation to address several safety issues.
  • Acción
    Siemens sent a Field Safety Notice to all affected customers informing them of a new software patch that they plan to install to address software issues. Customers were advised to notify anyone at their organization who should be aware of the information contained in the Notice. Customers were also advised to include the Field Safety Notice in their System Owner Manual, chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 610-219-4834.

Device

Device Recall Syngo RT Therapist, Accelerator, Linear, Medical
  • Modelo / Serial
    Model # 08162815, 8168754 Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    Syngo RT Therapist, Accelerator, Linear, Medical || Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
  • 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