Class 2 Device Recall LIFEPAK20 Defibrillator and Monitor

• Date Initiated by Firm: May 13, 2008
• Date Posted: September 08, 2008
• Recall Status: Terminated on March 20, 2011
• Recall Number: Z-2009-2008
• Recall Event ID: 48139
• 510(K)Number: K063119
• Product Classification: External Defibrillator - Product Code LDD
• Product: Physio-Control LIFEPAK¿ 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.
• Code Information: 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, 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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, 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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.
• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Todd Bandy; 425-867-4000 Ext. 4644
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 1,219 units
• Distribution: Product distributed to 1 US embassy, 97 domestic medical facilities nationwide, and 5 foreign consignees including the following countries: Germany, Netherlands, Canada, Australia and Hong Kong.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LDD and Original Applicant = MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.