Events

Retiro De Equipo (Recall) de Pinnacle3 Software Version 10.0

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, 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
    71117
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1643-2015
  • Fecha de inicio del evento
    2015-04-23
  • Fecha de publicación del evento
    2015-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136154
  • 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
    A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the philips pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. specifically, the dose engine is being passed the wrong snout position. the snout position is used to determine the penumbra of the beam which includes the calculation of the source si.
  • Acción
    Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (Contact Philips Customer Care Solutions Center at 1-800-722-9377).

Device

Pinnacle3 Software Version 10.0
  • Modelo / Serial
    "System Code S/N"  1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of MO, FL, OH
  • Descripción del producto
    Pinnacle3 Software Version 10.0, Model 459800200841. || Product Usage: || The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA