Events

Retiro De Equipo (Recall) de Device Recall Philips Ingenuity TF PET/CT Imaging Systems

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
    79696
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1392-2018
  • Fecha de inicio del evento
    2018-02-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163048
  • 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
    Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding.
  • Acción
    On February 15, 2018, the recalling firm notified customers of the recall via letter. The notice stated that to avoid the hazard of performing a rescan or reinjection, all users must be informed not to view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Customers were instructed to inform those who need to be aware within their organization or any organization wehre potentially affected devices have been transferred; transfer the notice to other affected organizations; and maintain the recall notice with their system Instructions For Use until the correction is made to the system. Customers were advised that Philips will be providing an updated Mass Storage Device that does not experience the same issue that will be provided at no additional cost to the customer. The Field Correction will be released in Q1 2018. Customers who need further information or support regarding the recall were directed to contact their local Philips representative. Customer Care Solutions Center: 1-800-722-9377.

Device

Device Recall Philips Ingenuity TF PET/CT Imaging Systems
  • Modelo / Serial
    Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
  • Descripción del producto
    Ingenuity TF PET/CT, Model No. 882442 || Product Usage: || The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
  • 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