Events

Retiro De Equipo (Recall) de Device Recall PercuNav, Tool Connection Unit

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 North America Co. Phillips.

¿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
    58993
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2769-2011
  • Fecha de inicio del evento
    2011-06-01
  • Fecha de publicación del evento
    2011-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100799
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Percunav tool connection unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.
  • Acción
    Philips Healthcare sent an "MEDICAL DEVICE CORRECTION" letter dated May 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The notification letter instructs customers to follow all directions in the Instructions for Use. A Philips Healthcare representative will schedule an appointment to replace the Tool Connection Unit at no charge to the customers. If further information is needed concerning this recall please call Philips Customer Service at 866-767-7822.

Device

Device Recall PercuNav, Tool Connection Unit
  • Modelo / Serial
    System Code Serial Numbers are: 03B8QR, B00DQ2, B00HZR, B00J3F, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, and B00PPP.   The Tool Connection Units with the following serial numbers are:  B00J0G, B00J0H, B00J0M, B00J0N, B00J0Q, B00J0R, B00J0X, B00J0Y, B00J10, and B00J20.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of CA, GA, OH, WA, and Washington DC, and the countries of Australia, India, Netherlands, and South Korea.
  • Descripción del producto
    The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. || The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. || It has a System Part Number: 989605392501, 989605396032, 989605395201. || Tool Connection Unit Part Number: 453561426002, 453561443201 || The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. || PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA