Events

Retiro De Equipo (Recall) de Device Recall Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1

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 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
    60933
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0805-2012
  • Fecha de inicio del evento
    2011-12-02
  • Fecha de publicación del evento
    2012-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106832
  • 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
    Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
  • Acción
    Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning this issue please contact your local Philips representative in the United States and Canada at 1-800-722-9377, and follow the recorded menu options to reach Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.

Device

Device Recall Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1
  • Modelo / Serial
    Product Code 882470, Seriel #'s: 7003-7006, 7008-7011, 7014, 7015, 7017-7026, 7031, 7034-7036, 7039, 7041, 7043, 7045, 7047, 7049, 7050-7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7073-7075, 7077, 7080, 7081, 7084-7087, 7089, 7093-7099, 7104, 7106-7108, 7112, 7114, 7115, 7118, 7120-7123, 7125, 7128, 7129, 7131, 7133, 7135, 7137-7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7165, 7166, 7168, 7170, 7173, 7174, 7176, 7177, 7181, 7183-187, 7193-7200, 7205, 7208, 7210, 7211, 7215, 7216, 7220, 7223 & 7224.  Product Code 882471, Seriel #'s: 7007, 7012, 7013, 7016, 7027-7030, 7032, 7042, 7044, 7055, 7057, 7059, 7061, 7063, 7065, 7067, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7109, 7110, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152-7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178-7180, 7182, 7188-7190, 7192, 7201-7204, 7206, 7209, 7212-7214, 7217-7219 & 7221.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Pakistan, Philippines, Poland, Russian Fed, Saudi, Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
  • Descripción del producto
    GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH || The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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