Events

Retiro De Equipo (Recall) de Device Recall MOSAIQ Oncology Information Systems

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 Impac Medical Systems 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
    62302
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1944-2012
  • Fecha de inicio del evento
    2012-06-08
  • Fecha de publicación del evento
    2012-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110188
  • 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
    Impac medical became aware of a problem with the recording of the wedge motor units in mosaiq when it resumes after a machine terminates/faults, the remaining wedge mu was being erroneously set to zero.
  • Acción
    A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.

Device

Device Recall MOSAIQ Oncology Information Systems
  • Modelo / Serial
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • Descripción del producto
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Dirección del fabricante
    Impac Medical Systems Inc, 100 Mathilda Place, 5th Floor, Sunnyvale CA 94086-6076
  • Empresa matriz del fabricante (2017)
    Impac Medical Systems Inc
  • Source
    USFDA