Events

Retiro De Equipo (Recall) de Device Recall BV25

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 Sales & Service Region No. America.

¿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
    29855
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1453-04
  • Fecha de inicio del evento
    2004-07-20
  • Fecha de publicación del evento
    2004-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34662
  • 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, Mobile - Product Code IZL
  • Causa
    Potential for c-arm to move due to loose screws.
  • Acción
    Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.

Device

Device Recall BV25
  • Modelo / Serial
    For all devices:  Part #s 980762000001, 980762000101, 980762010001, 980762010101, 980762020001, 980762020201, 984910000031, 984910000101, 989600006051, 989600006091, 989600006281, 989600006282, 989600007041, 989600007731  Site #s 59630, 104099, 101968, 101961, 101964, 59628, 59631, 59632, 101967, 101963, X1118, X1178, X1463, X1346, X1190, X1465, X0532, X1455, X1452, X1239, X1060, 300026, 300027, 13695, 10305, 13047, 13587, 13663, 35451, 13552, 15281, 13298, 13687, 14152, 13626, 15189, 13542, 15067, 10407, 13144, 15063, 14164, 13498, 13222, 13233, 13301, 15175, 13150, 82476, 15316, 13272, 5153, 13602, 15074, 14129, 15083, 13630, 82475, 13445, 10018, 15091, 59693, 13964, 13938, 13236, 4013, 6674, 6749, 59454, 6815, 6737, 6630, 6765, 6787, 81887, 6848, 5160, 6492, 4258, 6658, 6830,  6304, 101929, 6618, 6692, 6748, 4115, 6307, 6677, 4065, 4290, 6868, 6729, 4125, 6537, 6724, 6708, 4170, 6561, 76866, 5162, 5159, 4224, 6745, 5055, 6589, 34132, 34149, 35419, 38965, 35170, 34088, 34749, 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86928, 76421, 76366, 76177, 76061, 17478, 17462, 17463, 86927, 76032, 67082, 17479, 17532, 76419, 76418, 17619, 17526, 100718, 17461, 76158, 76447, 76171, 6744, 76096, 76157, 6725, 76422, 76176, 76169, 76175, 76139, 17685, 84925, 16131, 16132, 17180, 16583, 17257, 16582, 17345, 16141, 16771, 13416, 15087, 16000, 13551, 17188, 13540, 16719, 16732, 17548, 17518, 82474, 16663, 17173, 16069, 16717, 16037, 16746, 16058, 16060, 17200, 17342, 16012, 16014, 17332, 16571, 17451, 16072, 59683, 17375, 16059, 16620, 16105, 82939, 17308, 16702, 16022, 17181, 16076, 16099, 59479, 84727, 13888, 13563, 13524, 13434, 13490, 13357, 10347, 13428, 13536, 10370, 13889, 13435, 15204, 13671, 13419, 10304, 13343, 13303, 13647, 15146, 44098, 10082, 13390, 10084, 10297, 82481, 84726, 15263, 15172, 15170, 59690, 13437, 10003, 15276, 13495, 13270, 15171, 10078, 19056, 62545, 61969, 19510, 38706, 62262, 61911, 38260, 61865, 19258, 19010, 62370, 19051, 62005, 62336, 19449, 62267, 68212, 84922, 19090, 19549, 62570, 62263, 61894, 19293, 62510, 62465, 62269, 61825, 62466, 61821, 61858, 14024, 104651, 19147, 62349, 6198, 6200, 6909, 76845, 76946, 6199, 6201, 6809, 6514, 10143, 104034, 13395, 6515, 44846, 6801, 6827, 6746, 6593, 59478, 6529, 6731, 6361, 84797, 6760, 6736, 6666, 25618, 6690, 6518, 6768, 6156, 6595, 10373, 15237, 13535, 15238, 13347, 10311, 13493, 43110, 13375, 15308, 10372, 15174, 10316, 13342, 10326, 13597, 15307, 13393, 10315, 13526, 10433, 15249, 13505, 13352, 13944, 13553, 15169, 10365, 13676, 10248, 13438, 13638, X1123, 505404, 504453, X1396, 81879, X1378, 84926, 81864, 84975, 81868, 81880, X0275, 81865, 84923, 81877, 250049, 84933, 81871, 250121, X1530, 59685, 250833, 81888, 250774, 250047, X0555, X1513, 250818, X1210, 37051, 37662, 37675, 37664, 37816, 37270, 37225, 37686, 37909, 37650, 38001, 37495, 37956, 37331, 37032, 37468, 37829, 37160, 37198, 37137, 37855, 37854, 37243, 37122, 37671, 37947, 37311, 37085, 37180, 37437, 37106, 43254, 37333, 37207, 37711, 37610, 37890, 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4130, 25879, 28275, 19150, 25590, 31117, 40005, 67070, 26083, 25339, 26002, 25323, 40232, 25956, 25624, 25542, 505557, 28230, 25844, 25620, 46013, 26034, 25436, 26284, 28244, 61877, 25507, 25677, 25438, 25985, 26132, 26049, 37976, 25437, 14111, 25280, 28273, 25411, 25916, 25283, 25274, 25678, 26087, 25906, 84473, 25982, 25277, 37577, 25180, 25188, 25996, 28152, 40970, 28130, 26054, 28094, 28217, 25659, 26084, 28277, 28104, 26050, 25831, 28022, 25913, 25914, 26104, 26097, 38383, 31123, 25894, 26013, 28054, 504444, 250409, 250415, 250414, 250416, X0273, 250465, 250455, 84918, X0342, X0306, X0319, X0291, X1617, 250226, 504308, X0263, X0640, 250266, 504759, 505166, X1376, 250251, 250304, X1605, X0249, X0299, 13003, 250108, 19331, 62550, 62327, 19300, 82473, 61850, 19307, 61861, 38272, 62427, 62249, 62411, 62295, 19334, 19526, 19559, 62000, 61999, 62652, 19064, 58721, 65278, 59433, 83656, 59168, 81898, 59330, 43059, 81890, 58922, 59128, 81897, 58762, 84915, 58131, 59169, 58258, 58949, 59247, 58866, 81853, 58651, 81893, 58263, 84914, 84999, 59199, 59355, 81859, 81891, 58230, 59336, 58242, 58682, 84920, 59430, 59215, 81886, 84908, 81894, 58841, 58720, 84911, 59266, 59257, 59452, 58695, 58343, 59061, 58677, 59356, 58925, 58663, 59282, 58324, 59172, 59203, 59485, 59142, 101557, 68087, 67579, 68218, 67673, 67060, 67995, 67981, 67994, 68209, 68148, 67180, 38890, 67674, 68175, 68164, 67064, 67323, 85631, 59696, 82484, 4187, 38570, 10480, 59191, 13299, 58852, 82480, 38664, 82477, 59367, 59477, 104100, 59680, 58450, 58874, 17433, 83383, 59671, 82504, 58927, 84906, 10479, 58947, 104101, 104093, 59105, 84720, 10437, 13273, 38663, 504114, 59694, 58393, 84974, 58830, 59627, 83657, 59626, 59695, 59486, 59624, 104094, 59684, 82482, 59410, 83621, 82478, 6205, 59686, 59232, 10438, 59482, 59125, 82819, 38569, 58451, 82479, 84921, 83620, 83622, 58395, 59678, 59691, 59322, 82702, 59445, 59062, 61811, 59415, 61705, 61750, 61831, 61566, 61826, 61523, 62326, 61746, 61919, 62343, 62534, 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59687, 64433, 64410, 64446, 73439, 65247, 64364, 64420, 73881, 6196, 6190, 6207, 6598, 6114, 6871, 6805, 6800, 6412, 6115, 6371, 6335, 6197, 6195, 6188, 6179, 6804, 6791, 84795, 6534, 6670, 6540, 6014, 6186, 84796, 6099, 6747, 6769, 6779, 6341, 59481, 6189, 76821, 6187, X0563, X0562, X0558, X0559, X0535, X0538, X0258, X0564, X0526, X0311, X0316, X0300, 10067, X0301, X0906, X0092, 6487, X0547, X0549, X0519, X0548, X0551, X0313, X0560, X0552, 64514, 44731, 49166, 50170, 44847, 49627, 50093, 43442, 49596, 44856, 44561, 44849, 84917, 74082, 44704, 43025, 49165, 44758, 49296, 44756, 49692, 50144, 44984, 49229, 49718, 49075, 49182, 50092, 49282, 49260, 49185, 49183, 49172, 50049, 49257, 49731, 50041, 49154, 49706, 50106, 49179, 44961, 50133, 44853, 49292, 49714, 83032, 58379, 50123, 49353, 50198, 50005, 49031, 50124, 49580, 49728, 49387, 49499, 50071, 49683, 44762, 50082, 44775, 49673, 84919, 50084, 50000, 50172, 59689, 49607, 49459, 49048, 50001, 50059, 49373, 81876, 50008, 49726, 50040, 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The units are distributed to hospitals and medical centers throughout the U.S.
  • Descripción del producto
    BV25 Mobile X-Ray System
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Dirección del fabricante
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA