Events

Recall of LIFEPAK 20 Defibrillator/monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0925-2007
  • Event Initiated Date
    2007-04-27
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51986
  • Notes / Alerts
    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.
  • Extra notes in the data
    Defibrillator/monitor - Product Code MJK
  • 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.
  • 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.

Device

LIFEPAK 20 Defibrillator/monitor
  • Model / Serial
    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.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.
  • Product Description
    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.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA