Retiro De Equipo (Recall) de Device Recall MultiDiagnost Eleva

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 Electronics North America Corporation.

¿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
    74731
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2307-2016
  • Fecha de inicio del evento
    2016-07-19
  • Estado del evento
    Open, Classified
  • País del evento
  • 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
    The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag.
  • Acción
    On July 19, 2016, Philips sent a Field Safety Notice to all affected customers. Philips Field Service Engineers will add an independent safety catch free of charge.

Device

  • Modelo / Serial
    All serial numbers.  708032 System Serial numbers 100, 198, 354, 104, 367, 68, 428, 183, 414, 355, 289, 32, 269, 361, 160, 423, 50, 56, 205, 350, 71, 208, 254, 108, 222, 286, 257, 253, 327, 128, 125, 40, 265, 174, 164, 214, 411, 263, 178, 103, 394, 425, 374, 284, 229, 79, 37, 11, 312, 116, 226, 296, 44, 49, 219, 207, 227, 154, 317, 18, 87, 406, 88, 244, 233, 315, 376, 288, 112, 402, 206, 261, 215, 31, 422, 344, 338, 342, 339, 384, 12, 136, 415, 416, 137, 228, 46, 126, 276, 280, 51, 193, 54, 232, 140, 20, 270, 121, 25, 59, 60, 48, 21, 28, 196, 199, 380, 316, 159, 153, 172, 14, 62, 216, 75, 282, 294, 340, 102, 76, 64, 13, 231, 106, 305, 372, 366, 364, 77, 189, 24, 279, 166, 221, 349, 72, 42, 424, 0, 80, 217, 43, 213, 197, 413, 145, 318, 210, 341, 111, 343, 55, 292, 241, 151, 246, 0, 110, 29, 141, 362, 35, 143, 236, 278, 99, 133, 365, 85, 267, 132, 134, 163, 127, 266, 412, 142, 144, 293, 358, 399, 303, 308, 238, 239, 287, 243, 74, 310, 34, 345, 39, 69, 409, 162, 240, 281, 368, 382, 357, 277, 26, 165, 224, 170, 171, 392, 237, 119, 30, 396, 36, 38, 211, 255, 53, 146, 188, 404, 41, 81, 256, 16, 130, 184, 115, 107, 247, 275, 373, 169, 192, 248, 388, 389, 147, 352, 397, 417, 209, 98, 245, 92, 203, 314, 297, 290, 353, 383, 86, 309, 363, 251, 235, 379, 129, 225, 260, 405, 90, 84, 249, 139, 120, 329, 161, 218, 201, 347, 66, 283, 122, 33, 113, 114, 268, 180, 181, 182, 105, 298, 299, 109, 124, 295, 258, 194, 73, 57, 91, 369, 259, 403, 152, 138, 400, 93, 157, 118, 89, 15, 220, 212, 401, 61, 67, 135, 47, 148, 65, 264, 346, 173, 407, 123, 375, 291, 52, 393, 306, 307, 398, 190.  708036 System serial numbers 19, 40, 21, 8, 9, 16, 45, 11, 17, 14, 30, 31, 32, 48, 12, 50, 4, 15, 25, 13, 18, 42, 46, 41, 36, 35, 37, 47, 27, 43, 10, 5, 7, 24, 34, 29, 26.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA