Retiro De Equipo (Recall) de GEMINI TF 16 PET/CT Xray Diagnostic Imaging 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    In response to complaints received by philips medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their gemini pet/ct x-ray system units in the field. the firm believes that if these software defects were to recur, it could impact the performance of reliability of the these pet/ct system units.
  • Acción
    Philips Healthcare sent a "CPE CUSTOMER LETTER" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.


  • Modelo / Serial
    The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473, Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.
  • Descripción del producto
    Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. || The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source