BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-2065-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2065-2026
    Event ID
    98418
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    April 13, 2026
    Classification Date
    May 4, 2026
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003, United States

    Description

    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

    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.

    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

    Distribution

    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.

    Quantity

    206