Events

Retiro De Equipo (Recall) de MX8000 IDT CT SYSTEM

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
    52047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1568-2009
  • Fecha de inicio del evento
    2009-04-27
  • Fecha de publicación del evento
    2009-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81987
  • 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 KPS
  • Causa
    Philips healthcare has decided to recall the dental application on the extended brilliance workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the curved multi-planar reformation section (cmprs) views that were created with a short curve the right/left annotations will be reversed.
  • Acción
    An "URGENT - Field Safety Notice" dated April 27, 2009 was sent to all consignees via certified mail. The letter described the affected products, issue, and actions for the customer/user. The notification letter provides a work around until the new software is available. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.

Device

MX8000 IDT CT SYSTEM
  • Modelo / Serial
    Computed Tomography (CT) Model #455011202691, Serial Number: 5754, 6437, 6467, 6543, 6835, 7253, 7576, 7579, 7639, 8756, 8757, 10102, 10103, 10108, 10109, 10111-10114, 10116, 10117, 10119, 10120, 10122-10126, 10128, 10129, 10132, 10134-10144, 10146, 10151, 10154, 10158, 10161, 10163, 10167, 10173, 10174, 10175, 10179-10184, 10195, 10322, 10356, 10361, 10427, 10437, 10449, 10456, 10484, 10492, 10537, 10598, 10604, 10668, 10690, 10722, 10745, 10770, 10778, 10821, 10822, 10841, 10889, 10906, 10938, 10939, 10940, 10943, 10945, 10952, 10965, 10998, 11025, 11037, 11054, 11065, 11085, 11089, 11099, 11102, 11103, 11104, 11113, 11121, 11127, 11140, 11148, 11149, 11151, 11152, 11168, 11169, 11174, 11229, 11230, 11232, 11260, 11274, 11280, 11282, 11291, 11314, 11339, 11341, 11557, 11564, 11577, 11585, 11610, 11620, 11630, 11631, 11633, 11663, 11667, 11668, 11708, 11742, 11744, 11745, 11751, 11752, 11754, 11758, 11766, 11780, 11783, 11787, 11790, 11792, 11795, 11797, 11803, 11804, 11807, 11809, 11810, 11812, 11813, 11832, 11834, 11838, 11839, 11841, 11844, 11846, 11848, 11850, 11852, 11853, 11854, 11855, 11858, 11859, 11862, 11863, 11864, 11865, 11870, 11872, 11877, 11879, 11884, 11886, 11888, 11892, 11897, 11921, 11922, 11928, 11937, 11981-12064, 12071, 12073-12099, 12105, 12109, 12138, 12139, 12140, 12144, 12146, 12149, 12152, 12156, 12164, 12166, 12168, 12179, 12201, 12203, 12250-12259, 12272, 12276-12299, and 12450-12453.  Nuclear Medicine (NM) Model #455011002031, Serial Number: 4123, 7003, 7004, 7005, 7013, 7016, 7052, 7061, 7066, 7145, 7060, 7050, 7011, and 7020.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including DC (states of AL, AR, AZ, CO, DC, FL, IL, KY, LA, MA. ME, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, and WI) and countries of Africa, Albania, Austria, Australia, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Holland, India, Iraq, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden, Switzerland, Syria, Tahiti, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Venezuela.
  • Descripción del producto
    Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM). || The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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