Events

Retiro De Equipo (Recall) de Device Recall DigitalDiagnost Xray 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 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
    47477
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2422-2010
  • Fecha de inicio del evento
    2007-12-13
  • Fecha de publicación del evento
    2010-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69555
  • 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, stationary - Product Code KPR
  • Causa
    When using dicom print functionality, the printed images may contain data for the wrong patient.
  • Acción
    Philips Healthcare issued an "URGENT PRODUCT CORRECTION " letter dated March 10, 2008 to their consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Validate that image and patient information are correct on hard copy prints. 2) Reprint images that have mixed patient information, and re-check that image and patient information are correct. 3) Do not use printed images if the information is incorrect. The firm will issue the Field Change Order (FCO) 71200025 and the field service engineers will visit each consignee and conduct a software upgrade to solves the printing problem. The consignees may contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 71200025".

Device

Device Recall DigitalDiagnost Xray system
  • Modelo / Serial
    119 units are identified with Site Numbers:  59667, 82641, 82681, 86222, 86987, 86988, 103893, 103894, 104465, 104937, 104938, 105367, 504989, 505545, 506776, 532141, 536043, 536913, 539410, 540477, 540996, 541079, 541086, 541856, 541857, 542605, 542606, 543430, 544119, 544135, 544487, 544632, 544634, 544658, 545606, 547799, 548185, 548186, 548245, 548391, 548392, 548670, 549294, 549418, 549428, 549651, 549876, 549877, 549912, 550016, 550021, 550071, 550229, 550262, 550271, 550343, 550352, 550357, 550359, 550361, 550362, 550363, 550414, 550415, 550417, 550418, 550547, 550828, 550846, 550874, 550878, 550891, 550937, 551006, 551022, 551574, 551668, 551673, 552375, 552378, 552380, 552404, 552457, 552641, 553014, 553272, 553273, 553421, 553424, 553573, 553607, 554063, 554335, 554354, 554359, 554422, 554449, 554517, 554711, 554714, 554771, 555163, 555164, 555534, 555685, 555754, 553017, 531994, 535549, 543218, 543847, 547216, 549742, 550312, 551522, 552507, 552876, 552914, and 555119.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: including the states of AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI.
  • Descripción del producto
    DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. || The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.
  • 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