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.

Recall details

Manufacturer

Physio-Control, Inc.

Distributor

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.

Lot

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, 4

Risk classification

Class II

Area (FDA)

device

Country

United States