Events

Retiro De Equipo (Recall) de Device Recall COMPASS SW Version 3.1, Catalog Number CS10100

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 Iba Dosimetry Gmbh.

¿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
    70545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1212-2015
  • Fecha de inicio del evento
    2015-02-02
  • Fecha de publicación del evento
    2015-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134007
  • 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
    Error in the software. during internal tests of the current development version of the compass sw it was found that dose reconstruction for dmlc plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
  • Acción
    IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38

Device

Device Recall COMPASS SW Version 3.1, Catalog Number CS10100
  • Modelo / Serial
    Model : SW Version 3.1  Lot or Serial Number : n.a
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
  • Descripción del producto
    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • Dirección del fabricante
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • Empresa matriz del fabricante (2017)
    Ion Beam Applications SA
  • Source
    USFDA