Retiro De Equipo (Recall) de Device Recall BIPLANE XRay Imaging Systems with Velara Generator

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
    56093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2449-2010
  • Fecha de inicio del evento
    2010-02-04
  • Fecha de publicación del evento
    2010-09-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    A lock-up might occur inside the velara generator due to intermittent shorts inside the system. the problem can only resolved by a warm or cold system restart. in exceptional cases the power converters of the kvma unit in the generator are damaged and the system can not be restarted.
  • Acción
    On 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator. This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.

Device

  • Modelo / Serial
    Each unit is identified with a SITE number:  76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386,  104497, 104628, 104926, 104950, 104953, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504674, 504733, 504742, 504779, 504868, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 505903, 506008, 506026, 506069, 506119, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520275, 520582, 520666, 520688, 520756, 520793, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530653, 530654, 530660, 531649, 531758, 531799, 531926, 531939, 532152, 532218, 532240, 532241, 532383, 532614, 533288, 533290, 533397, 534131, 534156, 534786, 535345, 535761, 535775, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537175, 537593, 537631, 537804, 538028, 538095, 538099, 538157, 538172, 538387, 538409, 538514, 538516, 539213, 539326, 539628, 540184, 540237, 540461, 540721, 541237, 541238, 541239, 541276, 541577, 541589, 541590, 542382, 542413, 542557, 542714, 542963, 543289, 543411, 543690, 543879, 543953, 543989, 544306, 544395, 544543, 544635, 544656, 544668, 544844, 545025, 545262, 545396, 545518, 545583, 545604, 545753, 545882, 545884, 545997, 546013, 546119, 546149, 546569, 546906, 547173, 547215, 547431, 547642, 547715, 547769, 547823, 547922, 548005, 548020, 548036, 548082, 548140, 548288, 548383, 548618, 549202, 549242, 549368, 549370, 549903, 550198, 550691, 550758, 550812, 550935, 551855, 552355, 552599, 552639, 552969, 553685, 553699, 553766, 554763, 554802, 554970, 555293, 555299, 555356, 555834, 558604, 558945,  41443586, 41443609, 41443627, 41443647, 41443727, 41443765, 41443804, 41443909, 41444645, 41444647, 41444650, 41444689, 41444752, 41444816, 41445118, 41445432, 41445448, 41445501, 41445538, 41445615, 41445628, 41446230, 41446262, 41446773, 41455885, 41455897, 41455920, 41455925, 41455933, 41455944, 41455953, 41660520, 41780160, 41793290, 41795344, 41796154, 42046093, 42046440, 42057324, 42064058, 42067824, 42394072, 42479274, 42508759, 42553772, 42564341, 42625859, 42735090, 42891020, 42891095, 42891704, 43043666, 43058934, 43164789, 43173591, 43315510, 43436747, 43443622, 43453735, 43635004, 43670742, 43848923, 44028554, 44066424, 44584972, 44616211, 44654768, 44735751, and 44892370.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. || The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. || The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
  • Manufacturer

Manufacturer

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