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.
This recall has been terminated (originally issued June 9, 2007).
- Recall Initiated
- April 27, 2007
- Posted
- June 9, 2007
- Terminated
- March 23, 2012
- Recall Number
- Z-0925-2007
- Quantity
- 859 units
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.
Lot / Code Info
Affected 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. LP 20 defibrillator 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, 35216809, 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, 35244321; 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, 34770866.
Root Cause
Other
Action Taken
On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.