Events

Retiro De Equipo (Recall) de Device Recall FastPlan Versions 5.5 and 5.5.1

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 Varian Medical Systems Oncology Systems.

¿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
    56024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0836-2011
  • Fecha de inicio del evento
    2010-03-23
  • Fecha de publicación del evento
    2010-12-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92440
  • 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
    Due to software issue, an error occurs when performing cone planning using mri, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
  • Acción
    Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated. Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated. Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan. For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager. Phone: USA and Canada - 1-888-VARIANS (888-827-4265) Europe -+41 41 749 8844 E-mail: North America: support-america@varian.com Australia/New Zealand: support-anz@varian.com Europe: support-emea@varian.com South East Asia: seasia.apps.helpdesk@varian.com China/Asia: china.apps.helpdesk@varian.com Japan: Japan.Apps.Helpdesk@varian.com Latin America: soporte.al@varian.com Internet: Oncology Systems customer site - www.myvarian.com Varian Medical System public site - www.varian.com

Device

Device Recall FastPlan Versions 5.5 and 5.5.1
  • Modelo / Serial
    All codes start with HZ3: 0001, 0021, 0032, 0033, 0044, 0403, 0404, 0407, 0422, 0426, 0681, 0684, 0698, 0703, 0727, 2035, 2036, 2037, 2039, 2040, 2126, 3020, 3021, 3022, 3026, 9016, 9018, 9066, 9071, 9165, 0054, 0058, 0061, 0077, 0108, 0110, 0111, 0112, 0131, 0139, 0144, 0154, 0167, 0171, 0178, 0182, 0190, 0207, 0208, 0224, 0230, 0251, 0258, 0265, 0273, 0280, 0283, 0293, 0294, 0312, 0330, 0342, 0349, 0368, 0398, 0460, 0461, 0462, 0485, 0495, 0500, 0507, 0508, 0509, 0510, 0511, 0513, 0520, 0531, 0537, 0540, 0556, 0557, 0571, 0572, 0573, 0588, 0594, 0604, 0612, 0617, 0620, 0624, 0630, 0640, 0646, 0649, 0656, 0670, 0675, 0730, 0731, 0737, 0740, 0743, 0762, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2012, 2013, 2014, 2016, 2017, 2018, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2027, 2028, 2029, 2032, 2033, 2034, 2042, 2044, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2058, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2067, 2069, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2084, 2086, 2108, 2125, 3030, 3031, 3039, 3041, 3042, 3044, 3046, 3047, 3049, 3050, 3053, 3055, 3059, 3062, 3064, 5070, 6101, 6102, 6302, 6303, 7002, 7003, 7005, 7007, 7010, 7011, 7015, 7027, 7101, 8006, 8062, 9002, 9004, 9007, 9010
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan
  • Descripción del producto
    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA || Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA