Events

Rappel de Welch Allyn AED10

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Welch Allyn Protocol, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    45476
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0129-2008
  • Date de mise en oeuvre de l'événement
    2007-10-26
  • Date de publication de l'événement
    2007-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65555
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Automated External Defibrillator - Product Code MKJ
  • Cause
    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.
  • Action
    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

Welch Allyn AED10
  • Modèle / numéro de série
    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, NA037863, NA037864, NA037866, NA037867, NA037869, NA037870, NA037871, NA037872, NA037873, NA037874, NA037875, NA037876, NA037877, NA037878, NA037879, NA037880, NA037881, NA037882, NA037883, NA037884, NA037885, NA037886, NA037887, NA037888, NA037889, NA037890, NA037891, NA037892, NA037893, NA037894, NA037895, NA037896, NA037897, NA037898, NA037899, NA037900, NA037901, NA037902, NA037903, NA037904, NA037905, NA037906, NA037907, NA037908, NA037909, NA037911, NA037912, NA037913, NA037915, NA037918, NA037919, NA037920, NA037922, NA037923, NA037924, NA037926, NA037927, NA037928, NA037929, NA037930, NA037931, NA037932, NA037933, NA037934, NA037935, NA037936, NA037937, NA037939, NA037940, NA037942, NA037943, NA037944, NA037946, NA037947, NA037948, NA037950, NA037952, NA037954, NA037959, NA037960, NA037963, NA037969, NA037971, NA037972, NA037973, NA037975, NA037977, NA037978, NA037979, NA037980, NA038000, NA038004, NA038005, NA038012, NA038027, NA038028, NA038029, NA038030, NA038031, NA038032, 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, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide.
  • Description du dispositif
    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
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA