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AED Recalls
| Alert Details for #2007060115 (Released 6/14/2007 8:26 EDT) |
| Description: |
LIFEPAK 20 Defibrillator/Monitor |
| Manufacturer: |
Medtronic Emergency Response Systems,
Inc., Redmond, WA |
| Reason: |
White Screen Lock up: LifePak 20 defibrillators with software version 48 or
version 52 may experience an intermittent timing issue during the power on
sequence. This may lock up the device resulting in the monitor screen going
white, and may cause a potential delay or prevention of shock treatment. |
| Analyst Comments: |
Please click on the hyperlink in the Links field to view notification details,
dated April 27, 2007. Contact Medtronic Emergency Response Systems at Tel:
1-800-442-1142, or Tel: 425-867-4000. |
| Alert Type: |
Recall |
Source Alert Type: |
FDA Recall Class II |
| Domain: |
Biomedical Devices |
Source Type: |
FDA Enforcement Report |
| Distribution: |
United States and Worldwide |
Source Date: |
6/13/2007 |
| Product Description |
Model/Product Number |
Stock Identifiers |
Volume |
Recall ID |
| LIFEPAK 20 Defibrillator/Monitor. The device is an AC powered defibrillator
device with battery backup. The defibrillators are primarily used by healthcare
providers in device user facilities such as hospitals and clinics. |
Software version 48 or version 52; Part Numbers: 3202487-073 through -083;
3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036;
3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050 |
(a) Serial Numbers: DOMESTIC: 35246397, 35222145, 35222147, 35222171, 35246407,
35195082, 35202031, 35202041, 35213722, 35213784, 35216799, 35216801, 35219423,
35219450, 35213803, 35213807, 35216785, 35216786, 35216791, 35216793, 35216797,
35219435, 35219444, 35219446, 35219447, 35219448, 35219451, 35219452, 35219463,
35219464, 35219465, 35219467, 35219469, 35222141, 35232801, 35237779, 35237782,
35237784, 35237785, 35237786, 35237788, 35237789, 35237792, 35237793, 35237794,
35237800, 35237802, 35237803, 35239818, 35222169, 35232448, 35232925, 35233140,
35195289, 35213796, 35216787, 35219445, 35216794, 35216795, 35219441, 35219457,
35219459, 35232449, 35213805, 35216784, 35216788, 35219453, 35219454, 35219461,
35150433, 35150435, 35154911, 35158493, 35158499, 35161156, 35161163, 35161242,
35161244, 35161247, 35161249, 35161251, 35161252, 35161253, 35161255, 35161257,
35161258, 35161259, 35161260, 35161262, 35161263, 35161264, 35161267, 35161268,
35161269, 35161270, 35161271, 35161272, 35161273, 35161274, 35161275, 35161276,
35161278, 35161280, 35161281, 35161282, 35161283, 35161286, 35161291, 35166342,
35166344, 35166346, 35166351, 35166354, 35166355, 35166356, 35166357, 35166359,
35166363, 35166365, 35166367, 35166371, 35166372, 35166375, 35166377, 35166381,
35166385, 35166386, 35152846, 35152854, 35150429, 35150431, 35152839, 35152862,
35154877, 35154882, 35154908, 35158482, 35226477, 35226479, 35226482, 35226483,
35226484, 35226487, 35226489, 35226492, 35226493, 35226494, 35226496, 35226498,
35226499, 35226502, 35226515, 35226516, 35233136, 35233149, 35233154, 35233153,
35152851, 35152860, 35047103, 35065639, 35065640, 35065644, 35065649, 35065652,
35065655, 35088936, 35150422, 35150424, 35151610, 35151613, 35151615, 35152861,
35154873, 35154876, 35154883, 35154888, 35152847, 35152853, 35043904, 35084040,
35088934, 35150408, 35150414, 35151616, 35152845, 35154890, 35161171, 35161261,
35161265, 35161288, 35166347, 35166352, 35166353, 35166360, 35166364, 35166366,
35166368, 35166369, 35166370, 35166373, 35166374, 35166376, 35166378, 35166379,
35166380, 35166382, 35172605, 35172611, 35172613, 35226504, 35226510, 35226481,
35233138, 35226500, 35226506, 35226519, 35226520, 35226526, 35244234, 35213806,
35219432, 35219440, 35219442, 35244337, 35226486, 35226497, 35233137, 35245167,
35226518, 35202048, 35219443, 35222137, 35219472, 35222146, 35222153, 35222168,
35219449, 35246388, 35233122, 35233144, 35232447, 35166358, 35222142, 35219456,
35239851, 35158490, 35166361, 35161254, 35226505, 35226509, 35226513, 35226521,
35226524, 35226525, 35233120, 35233123, 35233125, 35233127, 35233129, 35233131,
35233132, 35233134, 35233135, 35233139, 35233141, 35233143, 35233148, 35233150,
35233155, 35233158, 30778465, 31004425, 35233110, 35233142, 35202046, 35213791,
35219458, 35222138, 35222150, 35222156, 35222167, 35222170, 35233116, 35233145,
35233147, 35233152, 35233126, 35213732, 35216789, 35219434, 35232452, 35232810,
35233099, 35233102, 35226378, 35226508, 35233117, 35213790, 35233115, 35233151,
35213801, 35213808, 35213809, 35213810, 35216780, 35219462, 35219466, 35219468,
35219470, 35222139, 35222151, 35222157, 35222163, 35226164, 35226165, 35226166,
35226167, 35226169, 35226170, 35232443, 35232450, 35232806, 35232809, 35232910,
35232915, 35232928, 35232931, 35233090, 35233092, 35233101, 35233103, 35233104,
35233108, 35233109, 35237791, 35065654, 35233133, 35244348, 35245143, 35245162,
35245165, 35246386, 35246391, 35246394, 35246396, 35246399, 35246402, 35246416,
35246420, 35246421, 35246422, 35246423, 35246425, 35246430, 35246431, 35246432,
35246433, 35249248, 35249255, 35222140, 35226490, 35226491, 35233156, 35232442,
35232451, 35219471, 35233128, 35222148, 35222165, 35246393, 35246417, 35246426,
35249256, 35249264, 35250340, 35250349, 35250352, 35250354, 35246406, 35246408,
35187570, 35187729, 35187733, 35187740, 35187745, 35187750, 35187753, 35187754,
35192461, 35192465, 35192467, 35192474, 35192475, 35192488, 35192492, 35192494,
35195062, 35195069, 35195073, 35195074, 35195075, 35195077, 35195085, 35195086,
35195240, 35195243, 35195245, 35195246, 35195247, 35195248, 35195249, 35195250,
35195251, 35195252, 35195253, 35195254, 35195255, 35195256, 35195257, 35195258,
35195259, 35195260, 35195261, 35195262, 35195263, 35195264, 35195265, 35195266,
35195267, 35195269, 35195270, 35195271, 35195272, 35195273, 35195274, 35195276,
35195277, 35195279, 35195280, 35195282, 35195283, 35195284, 35195285, 35195286,
35195287, 35195288, 35200196, 35200197, 35200198, 35202024, 35202025, 35202026,
35202027, 35202032, 35202033, 35202042, 35202043, 35202044, 35202045, 35202047,
35202049, 35202050, 35213720, 35213723, 35213724, 35213726, 35213728, 35213730,
35213781, 35213782, 35213783, 35213785, 35213786, 35213788, 35213789, 35213792,
35213793, 35213797, 35213798, 35213799, 35213800, 35213802, 35216776, 35216777,
35216778, 35216779, 35216781, 35216790, 35216792, 35216796, 35216802, 35216803,
35216807, 35216808, 3521609, 35216811, 35216812, 35216814, 35216815, 35216816,
35219424, 35219425, 35219426, 35219427, 35219428, 35219429, 35219430, 35219431,
35219433, 35219437, 35219438, 35219439, 35232921, 35233114, 35233146, 31339155,
35222160, 35222162, 35213795, 35226480, 35226501, 35226507, 30476108, 35222166,
35232444, 35232804, 30843087, 35154880, 35244327, 35244349, 35244354, 35245145,
35245163, 35245164, 35246384, 35246385, 35246398, 35216800, 35219436, 35233098,
35233106, and 35244321. |
859 units total. |
Z-0925-2007 |
| LIFEPAK 20 Defibrillator/Monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. |
Software version 48 or version 52; Part Numbers: 3202487-073 through -083;
3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036;
3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050 |
(a) Serial Numbers: INTERNATIONAL: 35258119, 35258120, 35258122, 35239852,
35258124, 35222143, 35222149, 35222155, 35239835, 35239836, 35239837, 35239838,
35239855, 35239860, 35242864, 35179778, 35244352, 35246400, 35237525, 35179763,
35179769, 35179775, 35179780, 35179785, 35179786, 35179789, 35200422, 35200431,
35247341, 35252146, 35257876, 35200433, 35247343, 35244353, 35252153, 35237798,
35237799, 35237801, 35237805, 35239739, 35239741, 35239826, 35239829, 35258121,
35258123, 35257953, 35237806, 35252152, 35252709, 35256669, 35258118, 35258135,
35265693, 35222154, 35222158, 35233100, 35239839, 35237808, 35258132, 35258141,
35246419, 35257965, 35257967, 35257969, 35257972, 35257973, 35179739, 35247342,
35258125, 35258127, 35258128, 35258129, 35246389, 35246404, 35250356, 35252123,
35252129, 35239744, 35239817, 35239844, 35239845, 35242868, 35179729, 35257875,
35257874, 35258130, 35237787, 35258139, 35258140, 35237523, 35239740, 35258137,
35258142, 35265695, 35258003, 35237526, 35237810, 35239841, 35265689, 35266602,
35266603, 35252150, 35258126, 35258133, 35265687, 35265690, 35265692, 35266598,
35272212, 35272220, 35272223, 35257974, 35257975, 35239834, 35257968, 35257980,
35257987, 35252147, 35252148, 35257992, 35257995, 35258004, 35258013, 35258015,
35258016, 35258136, 35269726, 35252155, 35257832, 35258131, 35257979, 35257996,
35272213, 35272216, 35252143, 35252151, 35257993, 35257998, 35237809, 35239859,
35242858, 35258138, 35265694, 35266597, 35239843, 35257813, 35257978, 35257984,
35258002, 35257864, 35258018, 35252145, 35252154, 35257877, 35257957, 35252121,
35252135, 35252138, 35222159, 35237796, 35237804, 35237807, 35239624, 35239743,
35239820, 35239821, 35239824, 35239827, 35239850, 35242862, 35266604, 35269733,
35269751, 35270068, 35270074, 35233096, 35233097, 35232800, 35179776, 35265686,
35269723, 35269724, 35269727, 35269729, 35269730, 35269731, 35269732, 35269734,
35269735, 35269739, 35269750, 35269752, 35269754, 35270072, 35270073, 35272211,
35272214, 35272215, 35272217, 35272219, 35272221, 35272222, 35272224, 35272225,
35272226, 35272227, 35272228, 35272229, 35272230, 35272231, 35272232, 35272233,
35272234, 35272235, 35272236, 35272237, 35272238, 35272239, 35272240, 35272241,
35272242, 35272243, 35272245, 35272246, 35272247, 35272248, 35272249, 35272250,
35272251, 35272252, 35272253, 35272254, 35272255, 35272256, 35272257, 35272258,
35272259, 35272260, 35272261, 35272263, 35272264, 35272265, 35272266, 35272267,
35272268, 35272269, 35272271, 35272272, 34973329, 34975026, 35233124, 35249251,
35252113, 35252149, 35252156, 35257865, 35257866, 35257955, 35257960, 35257961,
35257962, 35257963, 35257966, 35257970, 35257976, 35257977, 35257981, 35257983,
35257986, 35257988, 35257989, 35257990, 35257997, 35257999, 35258000, 35258005,
35258006, 35258014, 35233086, 35232924, 35032726, 35274442, 35275472, 35275473,
35275475, 35027242, 35154910, 35172853, 35257856, 35213787, 35237524, 35065618,
35084010, 35179700, 35269725, 35269736, 35269746, 35269747, 35269748, 35269749,
35272244, 35272262, 35272270, 35293823, 34944167, 34975015, 35027260, 35092960,
35112569, 35113161, 35154905, 35270066, 35275476, 35275477, 35275478, 35275481,
34988041, 35239854, 35275482, 34973330, 35269722, 35272218, and 34770866. |
859 units total. |
Z-0925-2007 |
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