Events

Retiro De Equipo (Recall) de Device Recall Odyssey

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 PerMedics, 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
    55280
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1609-2010
  • Fecha de inicio del evento
    2010-03-23
  • Fecha de publicación del evento
    2010-05-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90462
  • 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
    Anomaly 1, invalid characters in patient id error: currently, odyssey considers a valid id to be comprised of numbers and/or letters. if a patient id in a study contains a character other than a letter or number (including spaces). odyssey removes the invalid character when moving it to a patient folder. due to this, it is possible that two different patient studies could be listed within odyssey.
  • Acción
    A letter dated March 23, 2010 was mailed to customers acknowledging the anomalies and informed the reader that the mandatory version correcting the software will be provided by May 19, 2010. Customers with version 4.4 will receive 4.4.04:t hose with version 4.5 will receive 4.5.04; and those with version 4.6 will receive 4.6.01 containing the corrections to these issues. In the meantime, the following recommendations are provided. For Anomaly I . Invalid Characters in Patient ID Error, it 1s recommended that the users do not create patient IDS that contain characters other than letters or numbers. For Anomaly 2.0dysse.v Muchitle Library Collimator Type Error, it is recommended that the customer contact PerMedics ifany modifications to the library have been performed. The primary view should also be examined and used to detect and avoid the conditions causing the anomaly. Finally, independent field shape and monitor unit checks should be performed as part of a routine quality assurance program. For Anomaly 3, OOdyssey MLC Block Error, it is recommended to avoid using the MLC Block feature until the mandatory version correcting this anomaly is installed. If you need to use this feature, then it is recommended that a physical block tray is used during treatment for each beam that contains an Odyssey MLC Block. If customers believe a patient treatment has been affected by any of these issues, they should notify Customer Support as soon as possible at 877-4PerMed (877-473-7633) or support@permedics.com

Device

Device Recall Odyssey
  • Modelo / Serial
    Version 4.4 through 4.6
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.
  • Descripción del producto
    Odyssey || Intended use: Radiation treatment planning system
  • Manufacturer
    PerMedics, Inc.

Manufacturer

PerMedics, Inc.
  • Dirección del fabricante
    PerMedics, Inc., 1425 Victoria Ct, San Bernardino CA 92408-2853
  • Empresa matriz del fabricante (2017)
    PerMedics Inc
  • Source
    USFDA