Physio Control, Inc. Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Device Part Number: 3202459-061, 3202487-015, 3202487-073, 3202487-075, 3202487-078, 3202487-079, 3202487-100, 3202488-036, 3202488-038 and 3202488-040, Device SN number: 31013593, 31018361, 31521701, 32358182, 33035378, 35506844, 35506880, 35506886, 35506887, 35512605, 35514416, 35719026, 35719588, 35719590, 35719593, 35740798, 35740799, 35742042, 35742271, 35742274, 35744129, 35744131, 35744132, 35744133, 35744201, 35744905, 35744912, 35744913, 35744914, 35744917, 35744919, 35744921, 35744931, 35744933, 35744934, 35744935, 35744939, 35744940, 35744941, 35746673, 35746683, 35746685, 36090252, 36090256, 36090257, 36090258, 36090259, 36090262, 36090264, 36090265, 36090266, 36090268, 36090269, 36090270, 36090272, 36090273, 36090274, 36090275, 36090278, 36090279, 36090280, 36090281, 36090285, 36090286, 36090287, 36090289, 36090290, 36093885, 36101738, 36101739, 36101740, 36101742, 36101743, 36101745, 36101746, 36133741, 36133760, 36137373, 36139003, 36139004, 36139008, 36139015, 36139016, 36139017, 36139018, 36139019, 36139022, 36139027, 36139028, 36139029, 36139030, 36139032, 36141368, 36141385, 36141389, 36141390, 36141403, 36141404, 36141405, 36142719, 36142720, 36142721, 36142724, 36142727, 36142732, 36143803, 36143804, 36143816, 36143817, 36143818, 36143819, 36143820, 36143821, 36143822, 36143824, 36143827, 36143831, 36143832, 36143833, 36143834, 36143835, 36143836, 36143837, 36143838, 36143839, 36143840, 36143841, 36143842, 36143843, 36143844, 36143845, 36143846, 36143847, 36143850, 36143851, 36146450, 36146451, 36146452, 36146454, 36146455, 36146457, 36146458, 36146459, 36146460, 36146461, 36146463, 36146464, 36146465, 36146467, 36146469, 36146470, 36146471, 36146472, 36146473, 36146474, 36146475, 36146476, 36146477, 36146478, 36146479, 36146480, 36146482, 36146483, 36146484, 36153459, 36153460, 36153463, 36163333, 36163334, 36163335, 36163340, 36163341, 36163349, 36163351, 36163353, 36163354, 36163420, 36163423, 36164927, 36164928, 36164930, 36164931, 36164932, 36164934, 36164936, 36164937, 36164938, 36164942, 36164943, 36164949, 36164950, 36164951, 36164953, 36164956, 36164957, 36164961, 36164962, 36164963, 36164964, 36164966, 36164967, 36164968, 36164969, 36164970, 36164971, 36164972, 36164973, 36164974, 36164976, 36164977, 36164978, 36164979, 36164980, 36164981, 36164982, 36164983, 36168841, 36168842, 36168843, 36168844, 36168846, 36168847, 36168848, 36168849, 36168850, 36168851, 36168852, 36168853, 36168854, 36168855, 36168856, 36168857, 36168858, 36168859, 36168860, 36168861, 36168862, 36168863, 36168864, 36168865, 36168866, 36168867, 36168868, 36168869, 36168870, 36168871, 36168872, 36168873, 36168874, 36168875, 36168876, 36168877, 36168878, 36168880, 36168881, 36168882, 36168883, 36168884, 36168885, 36168886, 36168887, 36168888, 36168889, 36168890, 36168891, 36168892, 36168893, 36172860, 36172861, 36172862, 36172863, 36172864, 36172865, 36172866, 36172867, 36172868, 36172869, 36172870, 36172871, 36172872, 36172873, 36172874, 36172875, 36172876, 36172877, 36172878, 36172879, 36172880, 36172881, 36172882, 36172883, 36172884, 36172885, 36172886, 36172887, 36172888, 36172889, 36172890, 36172891, 36172892, 36172893, 36172894, 36172895, 36172896, 36172897, 36172898, 36172899, 36172900, 36172901, 36172902, 36172903, 36172904, 36172905, 36172906, 36172907, 36172908, 36172909, 36172910, 36172911, 36172912, 36172914, 36172915, 36172916, 36172918, 36172919, 36172920, 36172921, 36172922, 36172923, 36175050, 36175051, 36175052, 36175053, 36175054, 36175055, 36175056, 36175057, 36175058, 36175059, 36175060, 36175061, 36175062, 36175063, 36175064, 36175065, 36175066, 36175067, 36175068, 36175069, 36175070, 36175071, 36175072, 36175073, 36175074, 36175075, 36175077, 36175078, 36175079, 36175080, 36175081, 36175082, 36175083, 36175084, 36175085, 36175086, 36175087, 36175088, 36175089, 36175090, 36175091, 36175092, 36175093, 36175094, 36175095, 36175096, 36175097, 36175098, 36175099, 36175100, 36175101, 36175102, 36175103, 36178241, 36178242, 36178246, 36178247, 36178248, 36178249, 36178250, 36178251, 36178252, 36178254, 36178255, 36178256, 36178257, 36178258, 36178259, 36178261, 36178263, 36178278, 36178835, 36178836, 36178837, 36178838, 36178839, 36178840, 36178841, 36178842, 36178843, 36178844, 36178845, 36178847, 36178848, 36178849, 36178850, 36178851, 36178852, 36179224, 36179225, 36179227, 36179228, 36179229, 36179232, 36179233, 36179234, 36179235, 36179236, 36183644, 36183645, 36183646, 36186161, 36186162, 36186163, 36186165, 36186166, 36186168, 36186169, 36186170, 36186171, 36186173, 36186174, 36186175, 36186176, 36186177, 36186179, 36186180, 36186181, 36186184, 36186185, 36186187, 36186188, 36186191, 36186192, 36186195, 36186196, 36186197, 36186198, 36186199, 36186201, 36186204, 36186206, 36186207, 36186208, 36186209, 36186210, 36186219, 36188677, 36188678, 36188679, 36188680, 36188682, 36188683, 36188684, 36188687, 36188688, 36188689, 36188691, 36188692, 36188693, 36188694, 36188695, 36188696, 36188697, 36188698, 36188699, 36188702, 36188751, 36188753, 36188754, 36188755, 36188756, 36188757, 36188758, 36188759, 36188760, 36188761, 36188762, 36188763, 36188764, 36188765, 36188766, 36188767, 36188768, 36188769, 36188770, 36188771, 36188772, 36188773, 36188774, 36190699, 36190700, 36190701, 36190702, 36190703, 36190704, 36190705, 36190706, 36190707, 36190708, 36190709, 36190710, 36190711, 36190713, 36190714, 36190715, 36190716, 36190717, 36190718, 36200457, 36200459, 36200460, 36200461, 36200462, 36200463, 36200467, 36200468, 36200470, 36231195, 36231199, 36231204, 36231206, 36231895, 36231896, 36231902, 36231904, 36231944, 36231946, 36231948, 36231951, 36231952, 36232023, 36232024, 36232025, 36232026, 36232027, 36232028, 36232029, 36232030, 36232031, 36232257, 36232258, 36232259, 36232260, 36232261, 36232262, 36232474, 36232476, 36232477, 36232479, 36232480, 36232481, 36232482, 36232483, 36233781, 36233782, 36233783, 36233796, 36233797, 36233798, 36233799, 36233800, 36233801, 36233802, 36233803, 36233805, 36234054, 36234055, 36234056, 36234058, 36234060, 36234062, 36234063, 36234064, 36234343, 36234344, 36234345, 36234525, 36234526, 36234528, 36234529, 36234530, 36234531, 36234532, 36234636, 36234637, 36234639, 36234645, 36234647, 36236441, 36236442, 36244526, 36244527, 36244528, 36244529, 36244579, 36244581, 36244582, 36244583, 36244586, 36244588, 36244590, 36244591, 36244592, 36244593, 36244594, 36244595, 36244596, 36244598, 36244600, 36244601, 36245174, 36245176, 36245177, 36245178, 36245179, 36245181, 36245182, 36245183, 36245184, 36245185, 36245186, 36245188, 36245189, 36245190, 36245191, 36245192, 36245193, 36245194, 36245195, 36245196, 36245197, 36245198, 36245199, 36245201, 36245204, 36245205, 36245208, 36245209, 36245210, 36253898, 36253899, 36253900, 36253901, 36253902, 36253904, 36253905, 36253906, 36253907, 36253908, 36253909, 36253910, 36253911, 36253912, 36253914, 36253915, 36253916, 36253917, 36253918, 36253919, 36253920, 36253921, 36253922, 36253923, 36253924, 36253925, 36253926, 36253927, 36253928, 36253929, 36253930, 36253931, 36253932, 36253933, 36253934, 36253936, 36253937, 36253938, 36253939, 36253940, 36253941, 36253942, 36253943, 36253944, 36253945, 36253946, 36253947, 36253948, 36253949, 36253950, 36253951, 36253952, 36253953, 36253954, 36253955, 36253956, 36253957, 36253958, 36253959, 36257336, 36257338, 36257339, 36257341, 36257342, 36257361, 36257362, 36257363, 36257364, 36257365, 36257366, 36257368, 36257369, 36257370, 36257372, 36257373, 36257374, 36257375, 36257376, 36257378, 36257379, 36257380, 36257381, 36257383, 36257387, 36257388, 36257389, 36257390, 36257392, 36257393, 36257394, 36257395, 36257396, 36257397, 36257398, 36257399, 36257400, 36259179, 36260824, 36260825, 36260826, 36260827, 36260828, 36260829, 36260830, 36260831, 36260832, 36260833, 36260834, 36260835, 36260836, 36260837, 36260838, 36260839, 36260840, 36260841, 36260842, 36260843, 36260845, 36260846, 36260847, 36260848, 36260849, 36260850, 36260851, 36260852, 36260853, 36260854, 36260855, 36260856, 36260857, 36260858, 36260859, 36260860, 36260861, 36260862, 36260863, 36260864, 36260865, 36260866, 36260867, 36260868, 36260869, 36260870, 36260871, 36260872, 36260873, 36264639, 36264640, 36264641, 36264642, 36264643, 36264644, 36264645, 36264646, 36264647, 36264648, 36264649, 36264650, 36264653, 36264654, 36264655, 36264656, 36264657, 36264658, 36264660, 36264662, 36264663, 36264664, 36264666, 36264668, 36264669, 36264670, 36264671, 36264672, 36264674, 36264676, 36264678, 36264680, 36264681, 36264684, 36264686, 36264687, 36264689, 36264690, 36264692, 36264693, 36264695, 36267500, 36267501, 36267502, 36267503, 36267504, 36267505, 36267506, 36267507, 36267508, 36267510, 36267512, 36267513, 36267514, 36267515, 36267516, 36267517, 36267518, 36267519, 36267520, 36267521, 36267523, 36267524, 36267525, 36267526, 36267528, 36267529, 36267530, 36270152, 36270153, 36270155, 36270157, 36270158, 36270162, 36270163, 36270165, 36270166, 36270167, 36270168, 36270169, 36270170, 36270171, 36270175, 36270178, 36270180, 36273072, 36273077, 36273078, 36273079, 36273080, 36273081, 36273082, 36273085, 36273087, 36273090, 36273092, 36273093, 36273094, 36273095, 36273096, 36273934, 36273935, 36273937, 36273939, 36273979, 36273980, 36273981, 36273983, 36273984, 36273987, 36273988, 36273989, 36273990, 36273992, 36273993, 36273994, 36273995, 36273997, 36273998, 36273999, 36274000, 36274001, 36274002, 36274003, 36274006, 36274688, 36274689, 36274694, 36274695, 36274696, 36274698, 36274700, 36274702, 36274703, 36274705, 36274707, 36274708, 36274711, 36274713, 36274913, 36274914, 36274915, 36274916, 36274917, 36274920, 36274921, 36280952 and 36280953.
Products Sold
Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Device Part Number: 3202459-061, 3202487-015, 3202487-073, 3202487-075, 3202487-078, 3202487-079, 3202487-100, 3202488-036, 3202488-038 and 3202488-040; Device SN number: 31013593, 31018361, 31521701, 32358182, 33035378, 35506844, 35506880, 35506886, 35506887, 35512605, 35514416, 35719026, 35719588, 35719590, 35719593, 35740798, 35740799, 35742042, 35742271, 35742274, 35744129, 35744131, 35744132, 35744133, 35744201, 35744905, 35744912, 35744913, 35744914, 35744917, 35744919, 35744921, 35744931, 35744933, 35744934, 35744935, 35744939, 35744940, 35744941, 35746673, 35746683, 35746685, 36090252, 36090256, 36090257, 36090258, 36090259, 36090262, 36090264, 36090265, 36090266, 36090268, 36090269, 36090270, 36090272, 36090273, 36090274, 36090275, 36090278, 36090279, 36090280, 36090281, 36090285, 36090286, 36090287, 36090289, 36090290, 36093885, 36101738, 36101739, 36101740, 36101742, 36101743, 36101745, 36101746, 36133741, 36133760, 36137373, 36139003, 36139004, 36139008, 36139015, 36139016, 36139017, 36139018, 36139019, 36139022, 36139027, 36139028, 36139029, 36139030, 36139032, 36141368, 36141385, 36141389, 36141390, 36141403, 36141404, 36141405, 36142719, 36142720, 36142721, 36142724, 36142727, 36142732, 36143803, 36143804, 36143816, 36143817, 36143818, 36143819, 36143820, 36143821, 36143822, 36143824, 36143827, 36143831, 36143832, 36143833, 36143834, 36143835, 36143836, 36143837, 36143838, 36143839, 36143840, 36143841, 36143842, 36143843, 36143844, 36143845, 36143846, 36143847, 36143850, 36143851, 36146450, 36146451, 36146452, 36146454, 36146455, 36146457, 36146458, 36146459, 36146460, 36146461, 36146463, 36146464, 36146465, 36146467, 36146469, 36146470, 36146471, 36146472, 36146473, 36146474, 36146475, 36146476, 36146477, 36146478, 36146479, 36146480, 36146482, 36146483, 36146484, 36153459, 36153460, 36153463, 36163333, 36163334, 36163335, 36163340, 36163341, 36163349, 36163351, 36163353, 36163354, 36163420, 36163423, 36164927, 36164928, 36164930, 36164931, 36164932, 36164934, 36164936, 36164937, 36164938, 36164942, 36164943, 36164949, 36164950, 36164951, 36164953, 36164956, 36164957, 36164961, 36164962, 36164963, 36164964, 36164966, 36164967, 36164968, 36164969, 36164970, 36164971, 36164972, 36164973, 36164974, 36164976, 36164977, 36164978, 36164979, 36164980, 36164981, 36164982, 36164983, 36168841, 36168842, 36168843, 36168844, 36168846, 36168847, 36168848, 36168849, 36168850, 36168851, 36168852, 36168853, 36168854, 36168855, 36168856, 36168857, 36168858, 36168859, 36168860, 36168861, 36168862, 36168863, 36168864, 36168865, 36168866, 36168867, 36168868, 36168869, 36168870, 36168871, 36168872, 36168873, 36168874, 36168875, 36168876, 36168877, 36168878, 36168880, 36168881, 36168882, 36168883, 36168884, 36168885, 36168886, 36168887, 36168888, 36168889, 36168890, 36168891, 36168892, 36168893, 36172860, 36172861, 36172862, 36172863, 36172864, 36172865, 36172866, 36172867, 36172868, 36172869, 36172870, 36172871, 36172872, 36172873, 36172874, 36172875, 36172876, 36172877, 36172878, 36172879, 36172880, 36172881, 36172882, 36172883, 36172884, 36172885, 36172886, 36172887, 36172888, 36172889, 36172890, 36172891, 36172892, 36172893, 36172894, 36172895, 36172896, 36172897, 36172898, 36172899, 36172900, 36172901, 36172902, 36172903, 36172904, 36172905, 36172906, 36172907, 36172908, 36172909, 36172910, 36172911, 36172912, 36172914, 36172915, 36172916, 36172918, 36172919, 36172920, 36172921, 36172922, 36172923, 36175050, 36175051, 36175052, 36175053, 36175054, 36175055, 36175056, 36175057, 36175058, 36175059, 36175060, 36175061, 36175062, 36175063, 36175064, 36175065, 36175066, 36175067, 36175068, 36175069, 36175070, 36175071, 36175072, 36175073, 36175074, 36175075, 36175077, 36175078, 36175079, 36175080, 36175081, 36175082, 36175083, 36175084, 36175085, 36175086, 36175087, 36175088, 36175089, 36175090, 36175091, 36175092, 36175093, 36175094, 36175095, 36175096, 36175097, 36175098, 36175099, 36175100, 36175101, 36175102, 36175103, 36178241, 36178242, 36178246, 36178247, 36178248, 36178249, 36178250, 36178251, 36178252, 36178254, 36178255, 36178256, 36178257, 36178258, 36178259, 36178261, 36178263, 36178278, 36178835, 36178836, 36178837, 36178838, 36178839, 36178840, 36178841, 36178842, 36178843, 36178844, 36178845, 36178847, 36178848, 36178849, 36178850, 36178851, 36178852, 36179224, 36179225, 36179227, 36179228, 36179229, 36179232, 36179233, 36179234, 36179235, 36179236, 36183644, 36183645, 36183646, 36186161, 36186162, 36186163, 36186165, 36186166, 36186168, 36186169, 36186170, 36186171, 36186173, 36186174, 36186175, 36186176, 36186177, 36186179, 36186180, 36186181, 36186184, 36186185, 36186187, 36186188, 36186191, 36186192, 36186195, 36186196, 36186197, 36186198, 36186199, 36186201, 36186204, 36186206, 36186207, 36186208, 36186209, 36186210, 36186219, 36188677, 36188678, 36188679, 36188680, 36188682, 36188683, 36188684, 36188687, 36188688, 36188689, 36188691, 36188692, 36188693, 36188694, 36188695, 36188696, 36188697, 36188698, 36188699, 36188702, 36188751, 36188753, 36188754, 36188755, 36188756, 36188757, 36188758, 36188759, 36188760, 36188761, 36188762, 36188763, 36188764, 36188765, 36188766, 36188767, 36188768, 36188769, 36188770, 36188771, 36188772, 36188773, 36188774, 36190699, 36190700, 36190701, 36190702, 36190703, 36190704, 36190705, 36190706, 36190707, 36190708, 36190709, 36190710, 36190711, 36190713, 36190714, 36190715, 36190716, 36190717, 36190718, 36200457, 36200459, 36200460, 36200461, 36200462, 36200463, 36200467, 36200468, 36200470, 36231195, 36231199, 36231204, 36231206, 36231895, 36231896, 36231902, 36231904, 36231944, 36231946, 36231948, 36231951, 36231952, 36232023, 36232024, 36232025, 36232026, 36232027, 36232028, 36232029, 36232030, 36232031, 36232257, 36232258, 36232259, 36232260, 36232261, 36232262, 36232474, 36232476, 36232477, 36232479, 36232480, 36232481, 36232482, 36232483, 36233781, 36233782, 36233783, 36233796, 36233797, 36233798, 36233799, 36233800, 36233801, 36233802, 36233803, 36233805, 36234054, 36234055, 36234056, 36234058, 36234060, 36234062, 36234063, 36234064, 36234343, 36234344, 36234345, 36234525, 36234526, 36234528, 36234529, 36234530, 36234531, 36234532, 36234636, 36234637, 36234639, 36234645, 36234647, 36236441, 36236442, 36244526, 36244527, 36244528, 36244529, 36244579, 36244581, 36244582, 36244583, 36244586, 36244588, 36244590, 36244591, 36244592, 36244593, 36244594, 36244595, 36244596, 36244598, 36244600, 36244601, 36245174, 36245176, 36245177, 36245178, 36245179, 36245181, 36245182, 36245183, 36245184, 36245185, 36245186, 36245188, 36245189, 36245190, 36245191, 36245192, 36245193, 36245194, 36245195, 36245196, 36245197, 36245198, 36245199, 36245201, 36245204, 36245205, 36245208, 36245209, 36245210, 36253898, 36253899, 36253900, 36253901, 36253902, 36253904, 36253905, 36253906, 36253907, 36253908, 36253909, 36253910, 36253911, 36253912, 36253914, 36253915, 36253916, 36253917, 36253918, 36253919, 36253920, 36253921, 36253922, 36253923, 36253924, 36253925, 36253926, 36253927, 36253928, 36253929, 36253930, 36253931, 36253932, 36253933, 36253934, 36253936, 36253937, 36253938, 36253939, 36253940, 36253941, 36253942, 36253943, 36253944, 36253945, 36253946, 36253947, 36253948, 36253949, 36253950, 36253951, 36253952, 36253953, 36253954, 36253955, 36253956, 36253957, 36253958, 36253959, 36257336, 36257338, 36257339, 36257341, 36257342, 36257361, 36257362, 36257363, 36257364, 36257365, 36257366, 36257368, 36257369, 36257370, 36257372, 36257373, 36257374, 36257375, 36257376, 36257378, 36257379, 36257380, 36257381, 36257383, 36257387, 36257388, 36257389, 36257390, 36257392, 36257393, 36257394, 36257395, 36257396, 36257397, 36257398, 36257399, 36257400, 36259179, 36260824, 36260825, 36260826, 36260827, 36260828, 36260829, 36260830, 36260831, 36260832, 36260833, 36260834, 36260835, 36260836, 36260837, 36260838, 36260839, 36260840, 36260841, 36260842, 36260843, 36260845, 36260846, 36260847, 36260848, 36260849, 36260850, 36260851, 36260852, 36260853, 36260854, 36260855, 36260856, 36260857, 36260858, 36260859, 36260860, 36260861, 36260862, 36260863, 36260864, 36260865, 36260866, 36260867, 36260868, 36260869, 36260870, 36260871, 36260872, 36260873, 36264639, 36264640, 36264641, 36264642, 36264643, 36264644, 36264645, 36264646, 36264647, 36264648, 36264649, 36264650, 36264653, 36264654, 36264655, 36264656, 36264657, 36264658, 36264660, 36264662, 36264663, 36264664, 36264666, 36264668, 36264669, 36264670, 36264671, 36264672, 36264674, 36264676, 36264678, 36264680, 36264681, 36264684, 36264686, 36264687, 36264689, 36264690, 36264692, 36264693, 36264695, 36267500, 36267501, 36267502, 36267503, 36267504, 36267505, 36267506, 36267507, 36267508, 36267510, 36267512, 36267513, 36267514, 36267515, 36267516, 36267517, 36267518, 36267519, 36267520, 36267521, 36267523, 36267524, 36267525, 36267526, 36267528, 36267529, 36267530, 36270152, 36270153, 36270155, 36270157, 36270158, 36270162, 36270163, 36270165, 36270166, 36270167, 36270168, 36270169, 36270170, 36270171, 36270175, 36270178, 36270180, 36273072, 36273077, 36273078, 36273079, 36273080, 36273081, 36273082, 36273085, 36273087, 36273090, 36273092, 36273093, 36273094, 36273095, 36273096, 36273934, 36273935, 36273937, 36273939, 36273979, 36273980, 36273981, 36273983, 36273984, 36273987, 36273988, 36273989, 36273990, 36273992, 36273993, 36273994, 36273995, 36273997, 36273998, 36273999, 36274000, 36274001, 36274002, 36274003, 36274006, 36274688, 36274689, 36274694, 36274695, 36274696, 36274698, 36274700, 36274702, 36274703, 36274705, 36274707, 36274708, 36274711, 36274713, 36274913, 36274914, 36274915, 36274916, 36274917, 36274920, 36274921, 36280952 and 36280953.
Physio Control, Inc. is recalling Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold int due to A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will no. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.
Recommended Action
Per FDA guidance
On 5/13/08, the firm sent out letters to their domestic customers via Certified Receipt. The letter advised customers of the recall and instructed them to do the following, "Keep the defibrillator in service. If pressing the MANUAL button does not take the defibrillator out of AED mode, press one of the following keys to select manual mode: "ENERGY SELECT", "CHARGE", "PACER", OR "LEAD"... Please call your local Physio-Control service representative to arrange a service visit to replace the keypads." If you have questions, contact Technical Support at 1-800-442-1142, option 5.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026