CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Lifepak 15 Monitor/Defibrillator with End-Tidal CO2 option recalled

Physio-Control is recalling Lifepak 15 Monitor/Defibrillator with End-Tidal CO2 option, distributed nationwide in the US. The recall was initiated on 16 Jan 2017 and the FDA has classified it as Class II.

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Lot, batch or date codesLOT NUMBERS OF AFFECTED MODULE: Lot # 1506, 1520, 1532, 1544, and 1551. SERIAL NUMBERS OF AFFECTED DEVICES: 37930990, 38046566, 38130282, 38200467, 38374121, 38544771, 38561025, 38567823, 38577667, 38763423, 38805573, 39229417, 39656903, 39749477, 39757723, 39757723, 39905189, 40007558, 40007616, 40008237, 40074226, 40246186, 40637428, 40639397, 40881488, 41119327, 41441205, 41734558, 41908077, 42036185, 42721982, 42759819, 43273957, 43981182, 44128955, 44143195, 44143356, 44143399, 44143438, 44143481, 44143616, 44143674, 44143708, 44143786, 44143811, 44143814, 44143891, 44143894, 44143984, 44146278, 44146304, 44146408, 44148345, 44148588, 44148641, 44150897, 44151007, 44151084, 44151151, 44151156, 44151224, 44151362, 44151498, 44151591, 44151697, 44151790, 44151809, 44151862, 44151920, 44151995, 44152133, 44152249, 44152345, 44152361, 44156527, 44157048, 44157124, 44157189, 44157404, 44157697, 44157711, 44158485, 44158543, 44158614, 44158707, 44158804, 44159096, 44159162, 44159337, 44159406, 44159406, 44159491, 44159555, 44159615, 44159786, 44160212, 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44563710, 44563762, 44563860, 44564002, 44564274, 44564331, 44564357, 44564378, 44564406, 44564446, 44564452, 44564459, 44564474, 44564491, 44564516, 44571646, 44571660, 44571700, 44571723, 44571732, 44571754, 44571781, 44571841, 44571880, 44571902, 44571906, 44571915, 44571927, 44571952, 44572003, 44572006, 44572025, 44572028, 44572163, 44572171, 44572228, 44572353, 44572357, 44572374, 44572385, 44572398, 44572476, 44572478, 44572519, 44572521, 44572564, 44572595, 44572598, 44572660, 44572661, 44572727, 44572738, 44572785, 44572865, 44572951, 44573116, 44573148, 44573368, 44573387, 44573435, 44573448, 44573485, 44573487, 44573537, 44573557, 44573567, 44573719, 44573785, 44573861, 44573903, 44573905, 44573953, 44573985, 44573989, 44574340, 44574689, 44574715, 44574766, 44574832, 44574841, 44574929, 44574939, 44574948, 44574968, 44574969, 44575793, 44575795, 44575850, 44575857, 44575871, 44575898, 44575945, 44576111, 44576239, 44576245, 44576278, 44576280, 44576338, 44576358, 44576359, 44576392, 44576470, 44576543, 44576550, 44576647, 44576719, 44577928, 44588554, 44598727, 44598746, 44600358, 44600419, 44600456, 44600481, 44600579, 44600615, 44600675, 44600757, 44600812, 44600840, 44600870, 44600883, 44600897, 44600902, 44600925, 44600930, 44600966, 44600972, 44600988, 44601142, 44601189, 44601201, 44601234, 44601246, 44601412, 44601527, 44601556, 44601577, 44601650, 44601702, 44601708, 44601897, 44601985, 44602025, 44602032, 44602094, 44602108, 44602164, 44602205, 44602215, 44602354, 44602445, 44602547, 44602743, 44602752, 44602756, 44602811, 44602829, 44602903, 44602909, 44602974, 44602975, 44603076, 44603078, 44603163, 44603204, 44603240, 44603281, 44603282, 44603431, 44603452, 44603469, 44603607, 44603616, 44603679, 44603721, 44603731, 44603734, 44603805, 44603809, 44603843, 44603866, 44606180, 44606229, 44606230, 44606238, 44606273, 44606285, 44606311, 44606374, 44606468, 44606579, 44606593, 44606630, 44606648, 44606658, 44606669, 44606706, 44606865, 44606885, 44606901, 44606957, 44607025, 44607068, 44607153, 44607166, 44607207, 44607218, 44607300, 44607312, 44607314, 44607351, 44607386, 44607388, 44607443, 44607477, 44607531, 44607584, 44607678, 44607704, 44607756, 44607940, 44607946, 44607969, 44607980, 44608010, 44608013, 44608047, 44608055, 44608133, 44608157, 44608219, 44608260, 44608275, 44608345, 44608414, 44608415, 44608548, 44608573, 44608671, 44608680, 44608720, 44608756, 44608773, 44610008, 44610012, 44610014, 44610024, 44610024, 44610027, 44610067, 44610090, 44610126, 44610162, 44610255, 44610263, 44610341, 44610373, 44610401, 44610433, 44610439, 44610567, 44610577, 44610595, 44610713, 44610773, 44610988, 44611049, 44611241, 44611247, 44611289, 44611296, 44611297, 44611300, 44611420, 44611469, 44611512, 44611525, 44611526, 44611591, 44611640, 44611681, 44611717, 44611847, 44612167, 44612598, 44612615, 44612674, 44612710, 44612713, 44612827, 44612863, 44612966, 44612971, 44612991, 44613013, 44613036, 44613043, 44613066, 44613077, 44613108, 44613186, 44613196, 44613819, 44613895, 44613897, 44613910, 44613966, 44613987, 44614006, 44614055, 44614142, 44614154, 44614282, 44614294, 44614320, 44614322, 44614422, 44614430, 44614438, 44614447, 44614457, 44614484, 44614485, 44614488, 44614497, 44614531, 44614598, 44614813, 44616566, 44616574, 44616641, 44616659, 44616730, 44616766, 44616829, 44616831, 44616945, 44616965, 44617005, 44617026, 44617035, 44617068, 44617080, 44617130, 44617131, 44617162, 44617279, 44617286, 44617308, 44617336, 44617378, 44617502, 44617520, 44617614, 44617689, 44617789, 44617874, 44617880, 44617919, 44617935, 44617940, 44618021, 44618024, 44618122, 44618127, 44618163, 44618213, 44618251, 44618271, 44618279, 44618432, 44618434, 44618888, 44618920, 44618939, 44618958, 44618996, 44619032, 44619080, 44619087, 44619097, 44619121, 44619122, 44619153, 44619161, 44619177, 44619200, 44619276, 44619284, 44619424, 44619439, 44619444, 44619508, 44619524, 44619563, 44619680, 44619895, 44619903, 44619937, 44619939, 44619947, 44620084, 44620104, 44620121, 44620141, 44620159, 44620171, 44620174, 44620303, 44620322, 44620324, 44620349, 44620351, 44620406, 44620414, 44620429, 44620583, 44620591, 44620595, 44620598, 44620612, 44620622, 44620634, 44620635, 44620645, 44627576, 44627635, 44627723, 44627784, 44627853, 44627957, 44627996, 44628020, 44628081, 44628122, 44628169, 44628206, 44628257, 44628296, 44628355, 44628437, 44628736, 44628849, 44629106, 44629144, 44629194, 44629945, 44629990, 44630049, 44630082, 44630096, 44630141, 44630152, 44630182, 44631624, 44631675, 44631683, 44631692, 44631707, 44631740, 44631784, 44631801, 44631825, 44631833, 44632132, 44632201, 44632254, 44632323, 44632328, 44632437, 44632477, 44632591, 44633192, 44633423, 44633470, 44633508, 44633524, 44633539, 44633553, 44633605, 44633636, 44633646, 44633693, 44633774, 44633805, 44633835, 44633852, 44633855, 44633902, 44633942, 44639143, 44639236, 44639313, 44639424, 44639424, 44639469, 44639523, 44639609, 44639656, 44639681, 44639726, 44639745, 44640878, 44640937, 44640955, 44641005, 44641099, 44641177, 44641203, 44641249, 44641267, 44641384, 44641432, 44641501, 44641527, 44641571, 44641610, 44641653, 44641717, 44641750, 44641792, 44641842, 44641876, 44641920, 44641977, 44642057, 44642119, 44642295, 44642325, 44642480, 44642549, 44642590, 44642640, 44642723, 44642761, 44642881, 44643434, 44643691, 44643708, 44643751, 44643860, 44645351, 44645476, 44645539, 44645678, 44645797, 44645888, 44645918, 44646098, 44646149, 44646242, 44646294, 44646329, 44646422, 44646458, 44649033, 44650244, 44650429, 44650536, 44650561, 44650636, 44650657, 44651199, 44651270, 44651453, 44651641, 44651700, 44651788, 44651845, 44651880, 44651932, 44653456, 44657413, 44657442, 44657651, 44657706, 44657712, 44657801, 44657848, 44657870, 44657890, 44657906, 44657989, 44658026, 44658112, 44658141, 44658178, 44658193, 44658200, 44658210, 44658257, 44658300, 44658495, 44658541, 44658613, 44658657, 44658684, 44658710, 44658729, 44658764, 44658778, 44658801, 44658827, 44658843, 44658925, 44659003, 44659080, 44659110, 44659184, 44659297, 44660563, 44660611, 44660633, 44660672, 44660773, 44660904, 44661014, 44661079, 44661143, 44661169, 44661297, 44662053, 44662165, 44662265, 44662452, 44662547, 44662606, 44662630, 44662670, 44662729, 44662767, 44662800, 44662860, 44662887, 44662914, 44662998, 44663020, 44663073, 44663140, 44663172, 44663217, 44663236, 44663322, 44665217, 44665239, 44665257, 44665296, 44665513, 44665579, 44665635, 44665673, 44665827, 44665988, 44666113, 44666139, 44666211, 44666299, 44666384, 44666538, 44666587, 44666654, 44666912, 44666931, 44666993, 44667016, 44667052, 44667092, 44667193, 44667458, 44669797, 44669951, 44669983, 44670060, 44678760, 44678767, 44678820, 44679255, 44679261, 44679268, 44679279, 44679283, 44679289, 44679290, 44680774, 44686869, 45041613, and 45042034.

Quantity recalled2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1144-2017
FDA event ID: 76162
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2017
FDA classified: 7 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

16 Jan 2017	Recall initiated by company
7 Feb 2017	Classified by FDA	+22 days
15 Feb 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Product as listed by the FDA

LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.

Where it was distributed

Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.

Nationwide Alabama Georgia New York Puerto Rico South Carolina

Questions about this recall

Why was it recalled?

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Which lots are affected?

LOT NUMBERS OF AFFECTED MODULE: Lot # 1506, 1520, 1532, 1544, and 1551. SERIAL NUMBERS OF AFFECTED DEVICES: 37930990, 38046566, 38130282, 38200467, 38374121, 38544771, 38561025, 38567823, 38577667, 38763423, 38805573, 39229417, 39656903, 39749477, 39757723, 39757723, 39905189, 40007558, 40007616, 40008237, 40074226, 40246186, 40637428, 40639397, 40881488, 41119327, 41441205, 41734558, 41908077, 42036185, 42721982, 42759819, 43273957, 43981182, 44128955, 44143195, 44143356, 44143399, 44143438, 44143481, 44143616, 44143674, 44143708, 44143786, 44143811, 44143814, 44143891, 44143894, 44143984, 44146278, 44146304, 44146408, 44148345, 44148588, 44148641, 44150897, 44151007, 44151084, 44151151, 44151156, 44151224, 44151362, 44151498, 44151591, 44151697, 44151790, 44151809, 44151862, 44151920, 44151995, 44152133, 44152249, 44152345, 44152361, 44156527, 44157048, 44157124, 44157189, 44157404, 44157697, 44157711, 44158485, 44158543, 44158614, 44158707, 44158804, 44159096, 44159162, 44159337, 44159406, 44159406, 44159491, 44159555, 44159615, 44159786, 44160212, 44166262, 44166304, 44166470, 44166503, 44166514, 44166523, 44166536, 44166547, 44166631, 44171950, 44174110, 44174285, 44174322, 44174756, 44175011, 44175045, 44175070, 44175103, 44179307, 44179460, 44179499, 44179545, 44179576, 44179644, 44179750, 44180084, 44180141, 44180381, 44180443, 44180522, 44180584, 44180619, 44180789, 44180819, 44180917, 44182111, 44182155, 44185896, 44185922, 44185964, 44186134, 44186190, 44186249, 44186332, 44186361, 44186435, 44186555, 44186767, 44186789, 44186823, 44186871, 44186922, 44186961, 44187023, 44187363, 44187401, 44187447, 44187475, 44187739, 44187787, 44188141, 44195485, 44195502, 44195519, 44195593, 44195691, 44195713, 44195735, 44195749, 44195756, 44195861, 44195948, 44196025, 44196065, 44196096, 44196147, 44196198, 44196225, 44196266, 44196325, 44196414, 44196485, 44196832, 44196858, 44196898, 44196974, 44197026, 44197066, 44197146, 44197168, 44197212, 44197274, 44197295, 44197327, 44197348, 44197382, 44197397, 44197467, 44197511, 44198596, 44198678, 44198865, 44198906, 44198922, 44198961, 44198976, 44199088, 44199223, 44199386, 44199424, 44199478, 44199525, 44199806, 44199969, 44200010, 44200055, 44200186, 44200649, 44200724, 44200766, 44200807, 44200910, 44201002, 44201062, 44201120, 44201156, 44201243, 44201301, 44201342, 44201384, 44201466, 44201500, 44201551, 44203033, 44203091, 44203121, 44203172, 44203200, 44203234, 44203258, 44203316, 44203327, 44203472, 44203564, 44203654, 44203856, 44203886, 44203969, 44204052, 44204268, 44204540, 44204717, 44204782, 44204853, 44205142, 44205292, 44205329, 44205365, 44205404, 44205516, 44205592, 44205633, 44205705, 44205764, 44205875, 44205960, 44206055, 44206131, 44206166, 44206245, 44207820, 44207861, 44207882, 44208048, 44208105, 44208127, 44208152, 44208202, 44208320, 44208450, 44208494, 44209302, 44209524, 44209555, 44209797, 44209919, 44210007, 44210219, 44210271, 44210344, 44210396, 44210473, 44210493, 44210544, 44210619, 44210911, 44210940, 44210957, 44210984, 44211004, 44211021, 44211321, 44211355, 44211394, 44219958, 44220117, 44220142, 44220340, 44220358, 44220381, 44220403, 44220534, 44220569, 44220650, 44220734, 44220757, 44220782, 44220818, 44220856, 44220881, 44220919, 44220947, 44221011, 44221083, 44221152, 44221229, 44221426, 44221458, 44221503, 44222683, 44222703, 44222723, 44224099, 44224106, 44224120, 44224121, 44224139, 44224146, 44224176, 44224178, 44224194, 44224197, 44224243, 44224269, 44224285, 44224295, 44224306, 44224314, 44224315, 44224414, 44224419, 44224559, 44224635, 44224743, 44224804, 44224845, 44224979, 44225033, 44225060, 44225117, 44225180, 44225227, 44225242, 44225258, 44225272, 44225368, 44225610, 44225663, 44225706, 44225860, 44225939, 44226003, 44226063, 44226136, 44226183, 44226221, 44226231, 44226283, 44226384, 44226403, 44226417, 44226480, 44226493, 44226528, 44226564, 44226612, 44226624, 44226654, 44228007, 44228009, 44228037, 44228039, 44228053, 44228067, 44228097, 44228156, 44228202, 44228323, 44228343, 44228393, 44228394, 44228414, 44228492, 44228537, 44228650, 44228651, 44228709, 44228769, 44228931, 44228938, 44229062, 44229105, 44229133, 44229265, 44229280, 44229317, 44229411, 44229494, 44229497, 44229587, 44229629, 44229633, 44229787, 44229803, 44229860, 44229937, 44230308, 44230365, 44230388, 44230433, 44230497, 44230585, 44230632, 44230665, 44230754, 44230805, 44230839, 44230878, 44230887, 44230994, 44231014, 44231022, 44231124, 44233217, 44233228, 44233240, 44233286, 44233351, 44233416, 44233429, 44233508, 44233533, 44233547, 44233568, 44233602, 44233606, 44233618, 44233620, 44233705, 44233707, 44233769, 44233779, 44233843, 44233869, 44233920, 44233922, 44233952, 44233985, 44234024, 44234047, 44234092, 44234109, 44234117, 44234164, 44234238, 44234262, 44234283, 44234408, 44234505, 44234642, 44234673, 44234683, 44234697, 44234702, 44234719, 44234726, 44234767, 44234771, 44234803, 44234820, 44234840, 44234843, 44234882, 44234924, 44235000, 44265548, 44276069, 44276070, 44276165, 44276362, 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Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 76162

This product is part of a recall event; the main page for the event is Lifepak 12 Defibrillator/Monitor with End-Tidal CO2 option recalled.

Reported	Class	Recall	Company	Reason	Where
15 Feb 2017	CLASS II	Lifepak 12 Defibrillator/Monitor with End-Tidal CO2 option recalled	Physio-Control	Other	Nationwide

More recalls from Physio-Control

All 36

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 15 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak CR2 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide

Other Pacemakers & Defibrillators recalls

All 494

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide