Events

Retiro De Equipo (Recall) de Device Recall AutoSPECT Pro Software Application

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
    73776
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1504-2016
  • Fecha de inicio del evento
    2016-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144959
  • 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, tomography, computed, emission - Product Code KPS
  • Causa
    The autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90¿ or 180¿ relative to one another. however, certain gamma cameras allow for other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro and the results will likely be erroneous.
  • Acción
    On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative.

Device

Device Recall AutoSPECT Pro Software Application
  • Modelo / Serial
    M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128, 66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477, 66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451, 66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811, 67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173, 67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220, 67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122, 66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361, 66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
  • Descripción del producto
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. || Provides software applications used to process, analyze, and display medical images/data.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA