Retiro De Equipo (Recall) de Device Recall Precedence SPECT/CT System Upper Patient Pallet

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 Phillips Nuclear Medicine.

¿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
    51274
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0897-2011
  • Fecha de inicio del evento
    2009-01-26
  • Fecha de publicación del evento
    2011-01-12
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-01-13
  • Fuente del evento
    USFDA
  • 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
    Table, powered - Product Code INQ
  • Causa
    A problem has been identified with some upper patient pallets on precedence spect/ct system, which may reduce its load bearing capacity and may result in its cracking. if this were to happens, could pose a risk to patient.
  • Acción
    The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.

Device

  • Modelo / Serial
    Serial Numbers: 3000037, 3000048
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution only: Mexico and Saudi Arabia.
  • Descripción del producto
    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, || Model Number: 4535 602 50851, Catalog Number: 882350, || Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH || Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA