Events

Retiro De Equipo (Recall) de SharePlan 1.1

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 RAYSEARCH LABORATORIES AB.

¿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
    63186
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2444-2012
  • Fecha de inicio del evento
    2011-10-10
  • Fecha de publicación del evento
    2012-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112869
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Causa
    This notice concerns behavior of the shareplan that may be unexpected and not clearly described in the user manual. this behavior has not caused patient mistreatment or other incidents. however, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. the behavior appears, when importing rfa-files (.Asc).
  • Acción
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to pass on the notice to all those who need to be aware within their organization and to maintain awareness on this notice until the new labeling version has been received to ensure effectiveness of the corrective action. For questions regarding this recall call +46 8 54 50 61 42.

Device

SharePlan 1.1
  • Modelo / Serial
    version 1.2.1 (build number 1.3.1.10).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
  • Descripción del producto
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan || Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB