510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-0925-2007

LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The...

Physio Control, Inc. / initiated 2007-04-27 / Terminated / root cause: software
FDA source (opens on fda.gov)

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0925-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
Product
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.
Product code
MJK Dna Probe, Trichomonas Vaginalis
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.
Root cause tag
software
FDA root cause
Other
Action
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.
Quantity in commerce
859 units
Distribution
Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.
Product codes and lots
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, 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