Retiro De Equipo (Recall) de Welch Allyn AED10

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 Welch Allyn Protocol, Inc.

¿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
    45476
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0129-2008
  • Fecha de inicio del evento
    2007-10-26
  • Fecha de publicación del evento
    2007-11-06
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-11-09
  • 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
    Automated External Defibrillator - Product Code MKJ
  • Causa
    Failure to deliver shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.
  • Acción
    The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where the serial number is located - upper left hand corner of the back panel of the device. In addition the letter includes a response form, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with a replacement and new five (5) year warranty.

Device

  • Modelo / Serial
    Serial numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005, NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025, NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035, NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052, NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092, NA037093, NA037094, NA037095, NA037097, NA037098, NA037108, NA037110, NA037111, NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121, NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129, NA037132, NA037134, NA037139, NA037140, NA037143, NA037145, NA037146, NA037147, NA037148, NA037149, NA037150, NA037154, NA037155, NA037157, NA037158, NA037159, NA037160, NA037161, NA037162, NA037163, NA037164, NA037166, NA037167, NA037168, NA037169, NA037170, NA037171, NA037172, NA037173, NA037174, NA037175, NA037177, NA037179, NA037180, NA037182, NA037183, NA037184, NA037185, NA037186, NA037187, NA037188, NA037189, NA037190, NA037193, NA037194, NA037203, NA037206, NA037207, NA037209, NA037210, NA037213, NA037217, NA037219, NA037220, NA037221, NA037223, NA037225, NA037228, NA037234, NA037256, NA037354, NA037499, NA037511, NA037512, NA037513, NA037515, NA037516, NA037517, NA037518, NA037519, NA037523, NA037524, NA037525, NA037532, NA037533, NA037534, NA037535, NA037536, NA037538, NA037539, NA037540, NA037541, NA037542, NA037543, NA037544, NA037545, NA037546, NA037547, NA037548, NA037549, NA037550, NA037551, NA037552, NA037553, NA037554, NA037555, NA037556, NA037557, NA037558, NA037559, NA037560, NA037561, NA037562, NA037563, NA037564, NA037565, NA037566, NA037567, NA037568, NA037569, NA037570, NA037571, NA037572, NA037573, NA037574, NA037575, NA037576, NA037577, NA037578, NA037579, NA037580, NA037581, NA037582, NA037583, NA037584, NA037585, NA037586, NA037587, NA037588, NA037589, NA037590, NA037591, NA037592, NA037593, NA037594, NA037595, NA037596, NA037597, NA037598, NA037599, NA037600, NA037601, NA037602, NA037603, NA037604, NA037605, NA037606, NA037607, NA037608, NA037609, NA037610, NA037614, NA037615, NA037616, NA037617, NA037619, NA037620, NA037621, NA037622, NA037624, NA037625, NA037626, NA037627, NA037628, NA037629, NA037630, NA037631, NA037632, NA037633, NA037634, NA037635, NA037636, NA037637, NA037638, NA037639, NA037640, NA037641, NA037643, NA037644, NA037645, NA037646, NA037647, NA037648, NA037649, NA037650, NA037651, NA037652, NA037653, NA037654, NA037655, NA037656, NA037658, NA037659, NA037660, NA037661, NA037662, NA037663, NA037664, NA037665, NA037666, NA037667, NA037668, NA037669, NA037670, NA037671, NA037672, NA037673, NA037674, NA037675, NA037676, NA037677, NA037678, NA037679, NA037680, NA037681, NA037682, NA037683, NA037684, NA037685, NA037686, NA037688, NA037691, NA037696, NA037699, NA037700, NA037702, NA037704, NA037705, NA037706, NA037707, NA037708, NA037712, NA037713, NA037716, NA037717, NA037719, NA037720, NA037723, NA037724, NA037725, NA037729, NA037730, NA037731, NA037732, NA037738, NA037742, NA037743, NA037745, NA037746, NA037747, NA037749, NA037750, NA037751, NA037752, NA037757, NA037761, NA037762, NA037765, NA037766, NA037768, NA037769, NA037770, NA037773, NA037775, NA037779, NA037780, NA037781, NA037782, NA037784, NA037785, NA037786, NA037787, NA037788, NA037789, NA037790, NA037794, NA037795, NA037796, NA037797, NA037798, NA037800, NA037801, NA037802, NA037803, NA037804, NA037805, NA037806, NA037808, NA037809, NA037810, NA037811, NA037814, NA037816, NA037817, NA037818, NA037819, NA037821, NA037822, NA037823, NA037824, NA037825, NA037826, NA037828, NA037829, NA037831, NA037832, NA037834, NA037835, NA037836, NA037837, NA037838, NA037839, NA037840, NA037841, NA037842, NA037843, NA037844, NA037845, NA037846, NA037847, NA037848, NA037849, NA037850, NA037851, NA037852, NA037853, NA037854, NA037855, NA037856, NA037857, NA037858, NA037859, NA037860, NA037861, NA037862, 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NA038033, NA038035, NA038036, NA038037, NA038038, NA038039, NA038040, NA038041, NA038042, NA038043, NA038044, NA038045, NA038046, NA038047, NA038048, NA038049, NA038050, NA038051, NA038052, NA038053, NA038054, NA038056, NA038057, NA038058, NA038059, NA038060, NA038061, NA038062, NA038063, NA038064, NA038065, NA038066, NA038067, NA038068, NA038069, NA038070, NA038072, NA038073, NA038074, NA038075, NA038076, NA038077, NA038078, NA038080, NA038081, NA038082, NA038083, NA038084, NA038085, NA038086, NA038087, NA038088, NA038089, NA038090, NA038091, NA038092, NA038093, NA038094, NA038095, NA038096, NA038097, NA038098, NA038099, NA038100, NA038101, NA038102, NA038103, NA038104, NA038105, NA038106, NA038107, NA038108, NA038109, NA038110, NA038111, NA038112, NA038113, NA038114, NA038116, NA038117, NA038118, NA038119, NA038120, NA038121, NA038122, NA038123, NA038124, NA038125, NA038126, NA038127, NA038128, NA038129, NA038130, NA038131, NA038132, NA038133, NA038134, NA038135, NA038136, NA038137, NA038138, NA038139, NA038140, NA038141, NA038142, NA038143, NA038144, NA038145, NA038146, NA038147, NA038148, NA038149, NA038150, NA038151, NA038152, NA038153, NA038154, NA038155, NA038156, NA038157, NA038158, NA038159, NA038160, NA038161, NA038162, NA038163, NA038164, NA038165, NA038166, NA038167, NA038168, NA038169, NA038170, NA038171, NA038172, NA038174, NA038175, NA038176, NA038177, NA038178, NA038179, NA038180, NA038181, NA038182, NA038183, NA038184, NA038185, NA038186, NA038187, NA038188, NA038189, NA038190, NA038191, NA038193, NA038194, NA038195, NA038196, NA038197, NA038198, NA038199, NA038200, NA038201, NA038202, NA038203, NA038204, NA038205, NA038206, NA038207, NA038208, NA038209, NA038210, NA038211, NA038213, NA038214, NA038215, NA038216, NA038217, NA038218, NA038219, NA038220, NA038221, NA038222, NA038223, NA038224, NA038225, NA038226, NA038227, NA038228, NA038229, NA038230, NA038231, NA038232, NA038233, NA038234, NA038235, NA038236, NA038237, NA038238, NA038239, NA038240, NA038241, NA038242, NA038243, NA038244, NA038245, NA038246, NA038247, NA038249, NA038250, NA038251, NA038252, NA038253, NA038254, NA038255, NA038256, NA038257, NA038258, NA038259, NA038260, NA038261, NA038262, NA038263, NA038264, NA038265, NA038266, NA038267, NA038268, NA038269, NA038270, NA038271, NA038272, NA038273, NA038274, NA038275, NA038276, NA038277, NA038278, NA038279, NA038280, NA038281, NA038282, NA038283, NA038284, NA038285, NA038286, NA038287, NA038288, NA038289, NA038290, NA038291, NA038292, NA038293, NA038294, NA038295, NA038296, NA038297, NA038298, NA038299, NA038300, NA038301, NA038302, NA038303, NA038304, NA038305, NA038306, NA038307, NA038308, NA038309, NA038310, NA038311, NA038312, NA038313, NA038314, NA038315, NA038316, NA038317, NA038318, NA038319, NA038320, NA038321, NA038322, NA038323, NA038324, NA038325, NA038326, NA038327, NA038328, NA038329, NA038330, NA038331, NA038332, NA038333, NA038334, NA038335, NA038336, NA038337, NA038338, NA038339, NA038340, NA038341, NA038342, NA038343, NA038344, NA038345, NA038346, NA038347, NA038348, NA038349, NA038350, NA038351, NA038352, NA038353, NA038354, NA038355, NA038356, NA038357, NA038358, NA038359, NA038360, NA038361, NA038362, NA038363, NA038364, NA038365, NA038366, NA038367, NA038368, NA038369, NA038370, NA038371, NA038372, NA038373, NA038374, NA038375, NA038376, NA038377, NA038378, NA038379, NA038380, NA038381, NA038382, NA038383, NA038384, NA038385, NA038388, NA038389, NA038390, NA038392, NA038393, NA038396, NA038397, NA038398, NA038399, NA038400, NA038403, NA038404, NA038406, NA038407, NA038409, NA038410, NA038412, NA038413, NA038414, NA038415, NA038416, NA038417, NA038420, NA038421, NA038422, NA038423, NA038425, NA038427, NA038428, NA038429, NA038430, NA038432, NA038434, NA038435, NA038436, NA038437, NA038438, NA038439, NA038440, NA038441, NA038442, NA038443, NA038447, NA038448, NA038449, NA038450, NA038452, NA038453, NA038454, NA038455, NA038456, NA038457, NA038458, NA038459, NA038465, NA038467, NA038468, NA038471, NA038472, NA038473, NA038475, NA038476, NA038477, NA038478, NA038479, NA038483, NA038484, NA038485, NA038486, NA038489, NA038490, NA038492, NA038493, NA038494, NA038496, NA038498, NA038499, NA038500, NA038501, NA038502, NA038503, NA038504, NA038505, NA038506, NA038507, NA038508, NA038509, NA038510, NA038511, NA038512, NA038513, NA038514, NA038515, NA038516, NA038517, NA038518, NA038519, NA038520, NA038521, NA038522, NA038523, NA038524, NA038526, NA038527, NA038528, NA038529, NA038531, NA038532, NA038533, NA038536, NA038538, NA038539, NA038541, NA038542, NA038543, NA038544, NA038545, NA038547, NA038549, NA038550, NA038551, NA038552, NA038554, NA038555, NA038556, NA038557, NA038558, NA038559, NA038560, NA038561, NA038562, NA038564, NA038565, NA038566, NA038567, NA038568, NA038569, NA038570, NA038571, NA038572, NA038573, NA038574, NA038575, NA038576, NA038577, NA038578, NA038579, NA038580, NA038581, NA038582, NA038583, NA038585, NA038586, NA038587, NA038589, NA038590, NA038591, NA038592, NA038593, NA038594, NA038595, NA038596, NA038597, NA038598, NA038599, NA038600, NA038601, NA038602, NA038603, NA038604, NA038605, NA038607, NA038608, NA038609, NA038610, NA038612, NA038613, NA038614, NA038616, NA038618, NA038619, NA038624, NA038625, NA038626, NA038627, NA038628, NA038629, NA038630, NA038632, NA038634, NA038635, NA038636, NA038637, NA038638, NA038639, NA038640, NA038641, NA038642, NA038643, NA038644, NA038645, NA038646, NA038648, NA038649, NA038650, NA038651, NA038652, NA038653, NA038654, NA038658, NA038659, NA038662, NA038665, NA038666, NA038667, NA038668, NA038669, NA038671, NA038672, NA038673, NA038674, NA038675, NA038676, NA038677, NA038678, NA038679, NA038680, NA038683, NA038684, NA038685, NA038686, NA038687, NA038688, NA038690, NA038691, NA038692, NA038693, NA038694, NA038696, NA038697, NA038699, NA038700, NA038702, NA038704, NA038705, NA038706, NA038707, NA038709, NA038711, NA038712, NA038713, NA038714, NA038715, NA038716, NA038717, NA038718, NA038719, NA038720, NA038721, NA038722, NA038723, NA038725, NA038726, NA038727, NA038728, NA038729, NA038730, NA038731, NA038732, NA038733, NA038734, NA038735, NA038736, NA038737, NA038738, NA038739, NA038740, NA038741, NA038742, NA038743, NA038744, NA038745, NA038746, NA038747, NA038748, NA038749, NA038750, NA038751, NA038752, NA038753, NA038754, NA038755, NA038756, NA038757, NA038758, NA038759, NA038760, NA038761, NA038762, NA038763, NA038764, NA038765, NA038766, NA038767, NA038768, NA038769, NA038770, NA038771, NA038772, NA038773, NA038774, NA038775, NA038776, NA038777, NA038778, NA038779, NA038780, NA038781, NA038782, NA038783, NA038784, NA038785, NA038786, NA038787, NA038788, NA038789, NA038791, NA038792, NA038793, NA038794, NA038795, NA038796, NA038797, NA038798, NA038799, NA038800, NA038801, NA038802, NA038803, NA038804, NA038805, NA038806, NA038807, NA038808, NA038809, NA038810, NA038811, NA038814, NA038815, NA038816, NA038817, NA038818, NA038819, NA038820, NA038821, NA038822, NA038823, NA038824, NA038825, NA038826, NA038827, NA038828, NA038829, NA038831, NA038832, NA038833, NA038834, NA038835, NA038836, NA038837, NA038838, NA038839, NA038840, NA038841, NA038842, NA038843, NA038845, NA038846, NA038847, NA038848, NA038849, NA038850, NA038851, NA038852, NA038853, NA038854, NA038855, NA038856, NA038857, NA038858, NA038859, NA038860, NA038861, NA038862, NA038863, NA038864, NA038865, NA038867, NA038868, NA038869, NA038870, NA038871, NA038872, NA038873, NA038874, NA038875, NA038876, NA038877, NA038878, NA038879, NA038880, NA038881, NA038882, NA038883, NA038884, NA038885, NA038886, NA038887, NA038888, NA038889, NA038890, NA038892, NA038894, NA038896, NA038897, NA038898, NA038899, NA038900, NA038901, NA038902, NA038903, NA038904, NA038905, NA038906, NA038907, NA038908, NA038909, NA038911, NA038912, NA038913, NA038914, NA038915, NA038916, NA038917, NA038918, NA038919, NA038920, NA038921, NA038922, NA038923, NA038924, NA038925, NA038926, NA038927, NA038928, NA038929, 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  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide.
  • Descripción del producto
    Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA