Events

Retiro De Equipo (Recall) de Device Recall ALLURA XPER FD20

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
    57069
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0548-2011
  • Fecha de inicio del evento
    2009-05-26
  • Fecha de publicación del evento
    2010-12-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95398
  • 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, angiographic - Product Code IZI
  • Causa
    The printed circuit board (pcb) in the main-cabinet. further investigation revealed that a manufacturing error in the pcb is responsible for the reliability issue. as a result, the complete system may shut down and not re-start.
  • Acción
    Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems. If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.

Device

Device Recall ALLURA XPER FD20
  • Modelo / Serial
    Site numbers:  41443700, 41444446, 41444463, 41445125, 41445246, 41445254, 41445255, 41445256, 41445336, 41445427, 41445434, 41445578, 41445804, 41446150, 41586608, 41792527, 42063953, 42066520, 42225697, 42478916, 42635423, 42635426, 42812038, 42892018, 42892474, 42919054, 43082276, 43120325, 43165011, 43209312, 43209348, 43263118, 43340698, 43392727, 43420965, 43421081, 43433587, 43443629, 43445198, 43594036, 43594037, 43622121, 43704085, 43721256, 43973609, 43973613, 44004308, 44004309, 44038398, and 43592438.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
  • Descripción del producto
    ALLURA XPER FD20 || The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • 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