Physio-Control, Inc.: LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-00193

Company / brand

Physio-Control, Inc.

Product

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

Reason / hazard

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

Classification

Class II

Status

Ongoing

Distribution / sold at

US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.

Recall initiated

2026-04-13

Code info

Device/UDI/Serial Number: LIFEPAK 15/0088387391164815011543166573, 0088387387169015033143394891, 0088387387169015050743524360, 0088387387169015092843914574, 0088387387204815093043915122, 0088387387169016010444187447, 0088387387162116012044252611, 0088387387169016012644262721, 0088387387169016012644277082, 0088387387169016012744282280, 0088387387171316060244574340, 0088387387171316080444896329, 0088387387169016083144962804, 0088387387170617013145447229, 0088387387169017041245743786, 0088387387171317050945834209, 0088387387171317062845998142, 0088387387171317082846103043, 0088387387169017101046303288, 0088387387171317103146303092, 0088387387162117122146587130, 0088387387171317122646602003, 0088387387171317122846608783, 0088387387171317122946614788, 0088387387171318022246813507, 0088387387169018032946966267, 0088387387171318061947337396, 0088387387169018070547401928, 0088387387171318092747611441, 0088387387169018112947784931, 0088387387169018112947786317, 0088387387171318121847847661, 0088387387171318121847848950, 0088387387708118121947845317, 0088387387708118121947855371, 0088387387169018122047857172, 0088387387169018122047858660, 0088387387171318122847872868, 0088387387171319031248018370, 0088387387169019061248247559, 0088387387168319062748298704, 0088387387169019100848453060, 0088387387171319101448455890, 0088387387171319121848586351, 0088387387171319121948586599, 0088387387168320012848651507, 0088387387171320030548701689, 0088387387708120042848784975, 0088387387171320071648887706, 0088387387168320081748921846, 0088387387169020092448981398, 0088387387169020102649032288, 0088387387169020102649050140, 0088387387162120110249055931, 0088387387168320122949156402, 0088387387169021011149162067, 0088387387169021011149167463, 0088387387169021013049212578, 0088387387169021020949225869, 0088387387169021020949226060, 0088387387176821021949240566, 0088387387168321033149345530, 0088387387169021042149378981, 0088387387169021042649381781, 0088387387169021042749381576, 0088387387168321081849559854, 0088387387168321081949560127, 0088387387164521091649607224, 0088387387171321102149662806, 0088387377697122070750045009, 0088387387169022090150136719, 0088387387171322090850152289, 0088387387708122091350158293, 0088387387169022101950223934, 0088387387708122112150288760, 0088387387171322120150307353, 0088387387169023062850629377, 0088387387169023072450653772, 0088387387169023072450667197, 0088387387708123072850669746, 0088387387708123082850714419, 0088387387171323082950720588, 0088387387169023112150850129, 0088387387708123122050883524, 0088387388434824052251092313, 0088387387170624121151422867, 0088387387170624122351440213, 0088387387170624122351444039, 0088387388434824052251092313, 0088387387169019100848453060, 0088387387201715090843839264, 0088387387171318121847850793/ 38523489, 39736196, 40465345, 40717931, 40765749, 41130420, 41139184, 41420681, 41446039, 41446693, 41704583, 42221131, 42920956, 42921954, 43166573, 43394891, 43524360, 43914574, 43915122, 44187447, 44252611, 44262721, 44277082, 44282280, 44574340, 44896329, 44962804, 45447229, 45743786, 45834209, 45998142, 46103043, 46303288, 46303092, 46587130, 46602003, 46608783, 46614788, 46813507, 46966267, 47337396, 47401928, 47611441, 47784931, 47786317, 47847661, 47848950, 47845317, 47855371, 47857172, 47858660, 47872868, 48018370, 48247559, 48298704, 48453060, 48455890, 48586351, 48586599, 48651507, 48701689, 48784975, 48887706, 48921846, 48981398, 49032288, 49050140, 49055931, 49156402, 49162067, 49167463, 49212578, 49225869, 49226060, 49240566, 49345530, 49378981, 49381781, 49381576, 49559854, 49560127, 49607224, 49662806, 50045009, 50136719, 50152289, 50158293, 50223934, 50288760, 50307353, 50629377, 50653772, 50667197, 50669746, 50714419, 50720588, 50850129, 50883524, 51092313, 51422867, 51440213, 51444039, 51092313, 48453060, 43839264, 47850793, 38369584. LIFEPAK 1000/0088507469887815020943235807, 0088507469895315031343346860, 0088507469887815111944068667, 0088507469887815111944068669, 0088507469895316011844239775, 0088507469887816041444539726, 0088507469887817061745966118, 0088507469887817061745966121, 0088507469887817061745966122, 0088507469887817061745966126, 0088507469887817061945966131, 0088507469887817062945994506, 0088507469887817062946004311, 0088507469887817063046012479, 0088507469887818060547291148, 0088387381546519080648366102, 0088387381545820092948987376, 0088387381545821011249174469, 0088387381545821081349544565, 0088387381545821090249586700, 0088387381546521122249752235, 0088387381545822012649794992, 0088387381545822032949882696, 0088387381545822032949882698, 0088387381545822032949882819/ 34933095, 35096556, 35184465, 36153943, 36199099, 36560529, 36560531, 37119097, 37226402, 37330295, 38074718, 38074722, 38074727, 38074737, 38074741, 38074744, 38074745, 38074747, 38074748, 38074749, 38077938, 38077939, 38077940, 38077941, 38077944, 38378802, 38513659, 38656117, 38656121, 38656122, 38957375, 38957392, 38957397, 38957399, 38957402, 38972629, 38972677, 39775405, 39775406, 39775407, 39775415, 39964908, 40323073, 40412729, 40541187, 40584085, 40594714, 40707896, 40725568, 40725569, 40725571, 40725572, 40725575, 40725584, 40725582, 40725583, 41306695, 41692754, 41863786, 42504017, 42520778, 42803174, 42921847, 43235807, 43346860, 44068667, 44068669, 44239775, 44539726, 45966118, 45966121, 45966122, 45966126, 45966131, 45994506, 46004311, 46012479, 47291148, 48366102, 48987376, 49174469, 49544565, 49586700, 49752235, 49794992, 49882696, 49882698, 49882819. LIFEPAK 35/0088387377265224042251041190, 0088387377265224041851042010, 0088387377265224042251044581, 0088387376560924071151156570, 0088387376560924071151157072, 0088387376560924071151157449, 0088387376560924080651182632, 0088387376560924091251263526, 0088387376560924121051417585, 0088387376560925020451496956/ 51041190, 51042010, 51044581, 51156570, 51157072, 51157449, 51182632, 51263526, 51417585, 51496956. LIFEPAK 20e/0088387385386320082448935344, 0088387385386320082448935408, 0088387385386321080249537075/ 48935344, 48935408, 49537075

Product quantity

206

Voluntary mandated

Voluntary: Firm initiated

City

Redmond

State

WA

Country

United States

Event id

98418

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