Events

Retiro De Equipo (Recall) de Device Recall RayStationTherapy Treatment Planning System

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
    73575
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1712-2016
  • Fecha de inicio del evento
    2016-02-10
  • Fecha de publicación del evento
    2016-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144491
  • 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
    A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. the views can become unsynchronized with the stored data if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down. this bug does not affect dose computations, which are based on the stored system state.
  • Acción
    On February 10, 2016, RaySearch Laboratories distributed Field Safety, Medical Device Correction notices and Reply Forms to their customers via email. To determine if the software version you are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported. This bug does not affect dose computations. Dose is always computed based on the stored system state. Actions to be taken by the user include the following: Always release the left mouse button before using other keys or mouse buttons, If the warning message "Temporary items should not be visible on approval" is displayed or if there is some suspicion that the bug may have triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. All customers should educate planning staff and all users about this workaround. All customers are advised to inspect product and identify all installed units with the referenced software version number, then confirm that you have read and understood the notice by completing and returning the reply form. The completed reply form should be returned to Freddie Cardel, freddie.cardel@raysearchlabs.com, fax 888-501-7195. Customers with questions can call 1-877-778-3849, available east coast business hours all US working days.

Device

Device Recall RayStationTherapy Treatment Planning System
  • Modelo / Serial
    3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    **Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
  • Descripción del producto
    RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB