Events

Retiro De Equipo (Recall) de Device Recall Pinnacle3 Radiation Therapy 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 Philips Medical Systems (Cleveland), 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
    60549
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0594-2012
  • Fecha de inicio del evento
    2011-11-18
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105776
  • 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, nuclear magnetic resonance imaging - Product Code IYE
  • Causa
    Phillips medical systems have recently determined that a software (pinnacle3 software version 9.0) nonconformance can cause incorrect beam geometry.
  • Acción
    Consignees were sent on 11/18/11 a Philips "Urgent Medical Device Correction" letter dated 2011 Nov 16. The letter identified the affected product and described the Problem, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer/User, Actions Planned by Philips and Further information and Support. If customers observed the issue, they were to manually make the suggested change. In addition, customers were to place the letter in the Instructions for Use until otherwise notified. The firm will deliver 9.2 software release free of charge. Customers in North America are to contact Customer Care Solutions Center at 1-800-722-9377, if they have questions or need support concerning the recall.

Device

Device Recall Pinnacle3 Radiation Therapy Planning System
  • Modelo / Serial
    System Code # 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446111 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446041 453560446041 453560446041 453560446101 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446051 453560446041 453560446141 453560446141 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446181 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446061 453560446041 453560446041 453560446041 453560446201 453560446041 453560446041 453560446041 453560446041 453560446041
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and countries of AUSTRALIA, AUSTRIA, BELGIUM, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, and CANADA.
  • Descripción del producto
    Pinnacle3 Radiation Therapy Planning System, software version 9.0. || Model # Description || 453560446041 Pinnacle3 version 9.0 English || 453560446051 Pinnacle3 version 9.0 Simplified Chinese || 453560446061 Pinnacle3 version 9.0 Traditional Chinese || 453560446091 Pinnacle3 version 9.0 Dutch || 453560446101 Pinnacle3 version 9.0 French || 453560446111 Pinnacle3 version 9.0 German || 453560446141 Pinnacle3 version 9.0 Italian || 453560446161 Pinnacle3 version 9.0 Japanese || 453560446181 Pinnacle3 version 9.0 Spanish || 453560446201 Pinnacle3 version 9.0 Turkish || Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
  • Manufacturer
    Philips Medical Systems (Cleveland), Inc.

Manufacturer

Philips Medical Systems (Cleveland), Inc.
  • Dirección del fabricante
    Philips Medical Systems (Cleveland), Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA