Retiro De Equipo (Recall) de Intera

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
    37950
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0982-2007
  • Fecha de inicio del evento
    2007-04-30
  • Fecha de publicación del evento
    2007-06-27
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-09-21
  • 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
    magnetic resonance imaging system - Product Code LNH
  • Causa
    Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the mri site.
  • Acción
    On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.

Device

  • Modelo / Serial
    Site numbers: 10009, 10353, 10396, 10432, 13057, 13058, 38134, 38317, 41391, 41441, 62832, 63046, 76919, 82507, 82534, 82582, 82678, 82955, 83051, 83080, 83301, 83303, 83306, 83325, 83395, 83396, 83616, 83631, 83802, 83804, 83916, 83940, 83941, 83946, 83995, 84418, 84433, 84477, 84478, 84484, 84700, 84820, 84860, 84861, 84887, 84899, 85023, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85436, 85442, 85443, 85500, 85684, 85685, 85686, 85688, 86012, 86019, 86020, 86056, 86080, 86082, 86083, 86085, 86121, 86147, 86148, 86184, 86235, 86236, 86248, 86250, 86280, 86281, 86287, 86292, 86293, 86313, 86316, 86317, 86334, 86335, 86368, 86379, 86380, 86381, 86404, 86406, 86407, 86408, 86409, 86410, 86413, 86555, 86556, 86557, 86558, 86559, 86560, 86570, 86595, 86596, 86597, 86925, 86968, 87010, 87011, 87018, 87019, 87033, 87034, 87036, 87038, 87053, 87062, 87067, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87311, 87355, 87526, 87527, 87604, 87605, 87607, 100214, 100323, 100449, 100459, 100460, 100461, 100462, 100469, 100478, 100629, 100679, 100745, 100785, 100786, 100826, 100832, 100886, 100916, 101056, 101070, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101412, 101416, 101420, 101423, 101425, 101429, 101431, 101432, 101477, 101481, 101551, 101560, 101561, 101572, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101953, 101976, 102003, 102004, 102018, 102095, 102101, 102110, 102137, 102157, 102194, 102353, 102492, 102497, 102524, 102547, 102548, 102561, 102569, 102571, 102614, 102617, 102671, 102698, 102699, 102709, 102718, 102724, 102786, 102827, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103064, 103065, 103068, 103098, 103099, 103101, 103126, 103135, 103136, 103142, 103143, 103149, 103151, 103166, 103171, 103207, 103215, 103243, 103247, 103249, 103258, 103286, 103291, 103324, 103333, 103347, 103351, 103373, 103416, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103620, 103631, 103647, 103665, 103688, 103703, 103704, 103770, 103779, 103782, 103808, 103811, 103817, 103818, 103847, 103904, 103907, 103909, 103911, 103946, 104019, 104022, 104027, 104032, 104054, 104069, 104070, 104079, 104082, 104095, 104102, 104124, 104134, 104138, 104144, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104531, 104532, 104635, 104639, 104765, 104800, 104808, 104871, 104880, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104928, 104942, 105148, 105252, 105271, 105290, 105303, 105311, 105313, 105314, 105315, 105317, 105348, 105358, 105368, 105373, 105424, 105471, 105486, 105487, 105488, 105509, 105657, 105664, 105679, 105687, 105695, 105720, 105741, 105925, 105926, 105929, 105938, 225313, 250033, 250050, 250122, 250156, 250180, 250229, 250293, 250498, 250890, 500007, 500009, 500010, 500034, 500051, 504243, 504249, 504298, 504335, 504342, 504346, 504349, 504350, 504351, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504653, 504662, 504670, 504738, 504741, 504793, 504866, 504899, 504927, 504952, 504954, 504974, 504979, 505007, 505021, 505049, 505050, 505275, 505337, 505399, 505400, 505490, 505514, 505568, 505678, 505682, 505688, 505689, 505777, 505785, 505815, 505914, 505940, 505941, 505943, 506034, 506044, 506120, 506183, 506188, 506190, 506203, 506219, 506296, 506324, 506385, 506570, 506670, 506691, 506777, 506784, 519129, 519133, 519147, 519525, 519545, 519569, 519765, 519890, 520002, 520113, 520176, 520190, 520354, 520355, 520579, 520662, 520679, 520700, 520708, 520709, 520754, 520765, 521228, 521415, 521429, 521432, 521524, 521678, 521751, 521908, 521911, 521927, 521939, 522297, 522419, 522421, 522441, 530363, 530364, 530366, 530651, 531652, 531712, 531766, 531925, 531934, 532282, 532463, 532705, 532709, 532710, 532711, 533489, 533682, 533953, 534643, 534676, 534684, 534686, 534695, 534765, 534777, 535327, 535328, 535329, 535330, 535486, 535505, 536126, 536318, 536482, 536589, 536885, 537391, 537690, 537980, 538077, 538253, 538429, 538800, 538841, 539236, 539276, 539280, 539281, 539531, 539585, 539597, 539644, 539882, 540285, 540412, 540454, 540793, 540794, 540945, 541125, 541441, 541442, 541575, 541740, 541819, 541827, 541973, 542116, 542270, 542275, 542580, 543118, 543119, 543280, 543293, 543724, 543824, 543892, 543966, 543976, 544085, 544112, 544116, 545008, 545084, 545255, 545541, 545573, 545832, 545842, 545940, 545952, 545965, 545980, 546177, 546970, 547066, 547075, 547235, 547261, 547587, 547903, 547934, 547953, 547979, 547985, 548050, 548065, 548320, 549239, 549243, 549429, 549592, 549858, 550035, 550057, 550060, 550085, 550256, 550391, 550422, 550909, 551037, 551689, 552498, 552508, 555563, 556188, 556698, 557713, 557720, 41691292, 41923351, 43668550, 557722/ X1670, 557723/X1730, 557724/X1743, 557759/X1215, 557760/X1216, 557791/X1412, 557793/X1523, 557798/X1577, 557799/X1594, 557804/X1649, 557805/X1662, 557806/X1668, 557807/X1693, 557813/X1753, 557814/X1756, 557843/X1759, 558147/X1281, 558177/X1595, 558200/X1740, 558364/X1562, 558367/X1593, 558369/X1602, 558371/X1648, 558373/X1664, 558374/X1669, 558379/X1739, 558380/X1741, 558381/X1742, and 558382/X1744.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Units were distributed throughout the US to 1,078 hospitals and medical centers.
  • Descripción del producto
    Intera MRI
  • Manufacturer

Manufacturer

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