Events

Retiro De Equipo (Recall) de BV Pulsera Rel 2

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
    50066
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2463-2010
  • Fecha de inicio del evento
    2008-09-10
  • Fecha de publicación del evento
    2010-09-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74613
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Causa
    The c-arm rotation brake does not always function properly, and may not hold the c-arm position if the c-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. unwanted c-arm movement may cause the c-arm to collide with a patient. the brakes function properly if the c-arm is rotated to its maximum positions.
  • Acción
    Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377

Device

BV Pulsera Rel 2
  • Modelo / Serial
    Devices are identified with Site Numbers:  505029, 506745, 522087, 533824, 536622, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543862, 543947, 544191, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544622, 544972, 544984, 545085, 545102, 545103, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546680, 546687, 546786, 546788, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547221, 547284, 547288, 547299, 547375, 547602, 547603, 547643, 547656, 547684, 547710, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548354, 548366, 548385, 548397, 548398, 548569, 548602, 548653, 548700, 548702, 548731, 548733, 548743, 548781, 548782, 548790, 548853, 548929, 548972, 548975, 548984, 548992, 548996, 549005, 549006, 549021, 549025, 549027, 549049, 549059, 549060, 549061, 549063, 549064, 549065, 549070, 549071, 549072, 549112, 549113, 549114, 549115, 549116, 549117, 549118, 549119, 549120, 549121, 549122, 549125, 549126, 549127, 549128, 549129, 549130, 549132, 549133, 549136, 549137, 549139, 549140, 549142, 549143, 549144, 549171, 549218, 549221, 549235, 549241, 549260, 549262, 549272, 549273, 549274, 549275, 549287, 549301, 549403, 549404, 549405, 549406, 549407, 549519, 549520, 549528, 549540, 549563, 549596, 549618, 549674, 549694, 549706, 549727, 549728, 549732, 549733, 549749, 549752, 549822, 549855, 549878, 549964, 549968, 549993, 550022, 550023, 550056, 550066, 550113, 550121, 550123, 550125, 550128, 550131, 550136, 550183, 550184, 550186, 550189, 550190, 550200, 550252, 550264, 550298, 550372, 550379, 550416, 550426, 550427, 550428, 550450, 550523, 550524, 550541, 550542, 550562, 550603, 550649, 550651, 550762, 550808, 550819, 550820, 550844, 550856, 550865, 550879, 550923, 550925, 550971, 551013, 551020, 551023, 551024, 551033, 551034, 551039, 551128, 551132, 551133, 551134, 551135, 551136, 551137, 551139, 551142, 551190, 551191, 551212, 551262, 551264, 551277, 551292, 551293, 551300, 551329, 551331, 551332, 551333, 551366, 551367, 551368, 551369, 551373, 551381, 551384, 551388, 551400, 551422, 551425, 551427, 551428, 551444, 551445, 551473, 551478, 551487, 551506, 551507, 551513, 551518, 551524, 551528, 551529, 551530, 551531, 551532, 551533, 551534, 551536, 551537, 551538, 551539, 551546, 551547, 551548, 551549, 551580, 551591, 551592, 551594, 551605, 551621, 551624, 551646, 551685, 551686, 551687, 551712, 551713, 551723, 551729, 551764, 551797, 551813, 551820, 551822, 551840, 551854, 551882, 551885, 551952, 551967, 551992, 552014, 552015, 552016, 552017, 552018, 552034, 552070, 552075, 552103, 552122, 552157, 552161, 552182, 552225, 552226, 552228, 552229, 552230, 552231, 552232, 552233, 552234, 552235, 552236, 552237, 552239, 552240, 552241, 552242, 552243, 552244, 552245, 552246, 552247, 552248, 552249, 552250, 552251, 552262, 552265, 552291, 552292, 552297, 552298, 552299, 552308, 552310, 552312, 552327, 552334, 552335, 552336, 552365, 552386, 552401, 552402, 552403, 552405, 552406, 552439, 552445, 552452, 552459, 552460, 552462, 552471, 552483, 552510, 552511, 552525, 552542, 552547, 552561, 552565, 552566, 552569, 552573, 552578, 552581, 552618, 552621, 552632, 552638, 552642, 552643, 552670, 552678, 552688, 552689, 552690, 552715, 552716, 552722, 552723, 552724, 552739, 552740, 552840, 552841, 552842, 552868, 552869, 552912, 552921, 552964, 553015, 553016, 553057, 553058, 553071, 553072, 553150, 553161, 553162, 553163, 553177, 553181, 553182, 553192, 553205, 553211, 553218, 553219, 553221, 553274, 553286, 553289, 553292, 553293, 553296, 553307, 553310, 553327, 553359, 553360, 553364, 553442, 553443, 553449, 553473, 553474, 553500, 553503, 553535, 553562, 553564, 553565, 553587, 553589, 553591, 553596, 553600, 553640, 553642, 553650, 553654, 553683, 553693, 553694, 553730, 553768, 553772, 553832, 553833, 553851, 553855, 553861, 553874, 553875, 553879, 553880, 553882, 553898, 553903, 553916, 553958, 553959, 553967, 553972, 553973, 553988, 553990, 554005, 554012, 554014, 554025, 554032, 554034, 554093, 554195, 554199, 554200, 554214, 554217, 554218, 554219, 554235, 554248, 554272, 554273, 554274, 554303, 554315, 554336, 554340, 554345, 554347, 554353, 554372, 554378, 554379, 554381, 554407, 554420, 554421, 554428, 554429, 554430, 554432, 554472, 554473, 554474, 554475, 554476, 554500, 554501, 554502, 554505, 554543, 554552, 554553, 554570, 554611, 554621, 554636, 554637, 554638, 554661, 554663, 554667, 554679, 554681, 554688, 554724, 554736, 554742, 554761, 554778, 554799, 554812, 554817, 554837, 554838, 554839, 554849, 554859, 554864, 554870, 554871, 554883, 554889, 554891, 554892, 554893, 554894, 554895, 554949, 554959, 555002, 555003, 555005, 555009, 555023, 555024, 555025, 555036, 555054, 555113, 555132, 555133, 555134, 555135, 555142, 555148, 555151, 555156, 555157, 555168, 555169, 555172, 555181, 555185, 555217, 555275, 555301, 555319, 555326, 555342, 555353, 555354, 555379, 555391, 555400, 555410, 555411, 555443, 555469, 555479, 555494, 555495, 555499, 555500, 555501, 555502, 555532, 555533, 555573, 555601, 555602, 555604, 555606, 555645, 555646, 555648, 555658, 555682, 555692, 555693, 555695, 555696, 555704, 555727, 555734, 555735, 555746, 555783, 555793, 555824, 555967, 556006, 556015, 556022, 556023, 556024, 556026, 556045, 556051, 556052, 556057, 556067, 556075, 556081, 556082, 556083, 556100, 556125, 556126, 556130, 556137, 556138, 556145, 556160, 556162, 556165, 556180, 556182, 556183, 556193, 556199, 556204, 556205, 556206, 556207, 556220, 556221, 556222, 556223, 556239, 556254, 556255, 556265, 556266, 556320, 556335, 556382, 556461, 556462, 556473, 556474, 556481, 556501, 556510, 556518, 556529, 556536, 556542, 556544, 556545, 556546, 556562, 556563, 556564, 556570, 556578, 556588, 556614, 556615, 556623, 556628, 556645, 556646, 556660, 556702, 556713, 556777, 556802, 556809, 556818, 556825, 556838, 556841, 556845, 556849, 556853, 556854, 556865, 556866, 556887, 556889, 556920, 556935, 556942, 556950, 556958, 556985, 556997, 556998, 557017, 557019, 557020, 557035, 557036, 557047, 557058, 557062, 557146, 557149, 557184, 557195, 557199, 557210, 557213, 557220, 557229, 557242, 557250, 557252, 557254, 557255, 557273, 557274, 557281, 557282, 557284, 557408, 557440, 557441, 557442, 557443, 557444, 557445, 557455, 557463, 557487, 557489, 557490, 557499, 557506, 557521, 557528, 557530, 557531, 557564, 557565, 557566, 557570, 557582, 557587, 557589, 557591, 557592, 557593, 557596, 557614, 557615, 557617, 557635, 557636, 557637, 557642, 557665, 557690, 557708, 557709, 557711, 557712, 557914, 557915, 558004, 558228, 558229, 558230, 558231, 558232, 558235, 558236, 558246, 558247, 558248, 558249, 558250, 558260, 558386, 558387, 558388, 558389, 558390, 558391, 558392, 558393, 558394, 558395, 558418, 558419, 558427, 558440, 558441, 558444, 558452, 558453, 558455, 558500, 558522, 558523, 558531, 558567, 558611, 558632, 558633, 558634, 558635, 558638, 558647, 558654, 558693, 558697, 558698, 558699, 558790, 558835, 558843, 558844, 558847, 558861, 558862, 558867, 558924, 558925, 558966, 558967, 559003, 559026, 559045, 559068, 559101, 559251, 559254, 559294, 559319, 559322, 559331, 559363, 559364, 559415, 559417, 559423, 559448, 559495, 559533, 559537, 559563, 559584, 559655, 559658, 559679, 559690, 559775, 559877, 559880, 559924, 559963, 41416302, 41416329, 41443563, 41443590, 41443601, 41443603, 41443605, 41443611, 41443616, 41443668, 41443673, 41443675, 41443721, 41443746, 41443748, 41443764, 41443831, 41443872, 41444449, 41444577, 41444618, 41445304, 41445356, 41445415, 41445423, 41445436, 41445441, 41445453, 41445476, 41445484, 41445487, 41445504, 41445506, 41445509, 41445521, 41445528, 41445534, 41445553, 41445599, 41445657, 41445717, 41445718, 41445728, 41445740, 41445741, 41445775, 41445791, 41445794, 41445802, 41445815, 41445894, 41445895, 41445911, 41445915, 41445921, 41445922, 41445933, 41446009, 41446060, 41446086, 41446088, 41446095, 41446183, 41446185, 41446186, 41446243, 41446272, 41446285, 41446310, 41446396, 41446424, 41446454, 41446667, 41446770, 41446789, 41455878, 41490306, 41490307, 41490308, 41490309, 41490311, 41490312, 41490314, 41490315, 41490316, 41490318, 41555898, 41556812, 41566245, 41566346, 41576092, 41577033, 41577782, 41585081, 41585198, 41587498, 41611719, 41611720, 41616194, 41616195, 41620935, 41620966, 41620994, 41621991, 41622664, 41630562, 41632199, 41632201, 41645797, 41647329, 41657683, 41658375, 41658562, 41658563, 41658564, 41658565, 41701158, 41701180, 41701188, 41710489, 41712352, 41712375, 41713383, 41725527, 41725782, 41726634, 41727262, 41748088, 41748089, 41750637, 41757081, 41757083, 41757225, 41757995, 41757996, 41765919, 41765927, 41768050, 41768058, 41768059, 41780151, 41780384, 41781354, 41781423, 41783605, 41783704, 41792689, 41793821, 41793882, 41794417, 41795593, 41796073, 41796150, 41796152, 41832433, 41833197, 41833714, 41885442, 41885443, 41898013, 41936644, 41938323, 41939336, 41953816, 41953942, 41957602, 41980506, 41980509, 41986345, 41986348, 41986353, 41986793, 41987067, 41987951, 42000523, 42028669, 42037365, 42053457, 42056714, 42057341, 42084783, 42182116, 42182142, 42182150, 42182154, 42182158, 42250965, 42440473, 42442866, 42451804, 42451806, 42453900, 42453911, 42453921, 42454149, 42454796, 42455282, 42455439, 42470770, 42473457, 42473479, 42474563, 42474568, 42474574, 42474575, 42474585, 42474590, 42495270, 42551935, 42553919, 42566165, 42566168, 42573106, 42573107, 42573110, 42573112, 42573118, 42573165, 42573189, 42573191, 42573192, 42573195, 42573198, 42573203, 42573399, 42573407, 42573428, 42573429, 42598765, 42601652, 42602299, 42607825, 42608271, 42608333, 42608337, 42616997, 42622640, 42624734, 42624941, 42625869, 42626199, 42627935, 42627942, 42635567, 42635590, 42636398, 42636399, 42638526, 42639032, 42657622, 42669138, 42672347, 42672459, 42673153, 42673554, 42673588, 42673589, 42673591, 42673595, 42673598, 42677402, 42677649, 42677713, 42678207, 42678208, 42678315, 42678321, 42678333, 42678347, 42678370, 42683563, 42692086, 42708001, 42708002, 42723370, 42723386, 42723388, 42724008, 42727418, 42736788, 42791443, 42792818, 42792938, 42799382, 42825111, 42826877, 42861795, 42861808, 42861819, 42861834, 42865440, 42865605, 42865606, 42865645, 42865656, 42865948, 42865949, 42865969, 42866193, 42866916, 42869019, 42869087, 42869138, 42869153, 42869214, 42877739, 42877741, 42877743, 42877745, 42877747, 42877749, 42877750, 42877752, 42877781, 42877789, 42877790, 42877794, 42877795, 42877796, 42877799, 42877803, 42877813, 42877814, 42878126, 42878153, 42878225, 42878231, 42878253, 42878264, 42878367, 42878368, 42878374, 42878380, 42878386, 42878440, 42879078, 42879150, 42879151, 42879169, 42879170, 42879172, 42879218, 42879230, 42879240, 42879774, 42879775, 42879776, 42879777, 42879778, 42879779, 42880753, 42880965, 42891050, 42891052, 42891959, 42892002, 42892363, 42892402, 42892422, 42911778, 42916162, 42916268, 42916313, 42916328, 42917165, 42917166, 42917171, 42917176, 42917278, 42917289, 42943097, 42967767, 42968938, 43043495, 43056780, 43057942, 43083516, 43120974, 43125863, 43151260, 43181183, 43209156, 43209392, 43246451, 43326065, 43338394, 43404708, 43436018, 43440501, 43440516, 43440517, 43443832, 43444437, and 43689105.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: Throughout the US.
  • Descripción del producto
    Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
  • 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