LIFEPAK 15 MONITOR/DEFIBRILLATOR

This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.

Cardiovascular Devices

3

No

worldwide

The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical || personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX

SERIAL NUMBERS:  42738872, 44554102, 42701550, 42702539, 42730815, 42800549, 42803986, 42862109, 42884428, 42944609, 42989327, 43022460, 43040692, 43048791, 43066974, 43116838, 43116994, 43119477, 43132954, 43133203, 43133221, 43133906, 43154308, 43154457, 43156695, 43161425, 43163930, 43164076, 43164158, 43166133, 43206034, 43210019, 43219622, 43226291, 43230032, 43232487, 43232904, 43247389, 43251050, 43253506, 43253916, 43254032, 43258901, 43293290, 43321556, 43388132, 43388137, 43388541, 43405542, 43407947, 43409346, 43429508, 43465372, 43472036, 43472591, 43480824, 43489606, 43492883, 43576021, 43616526, 43641893, 43691775, 43715563, 43735849, 43764249, 43800357, 43805213, 43825370, 43826635, 43843347, 43869096, 43884778, 43922984, 43938506, 43947198, 43962139, 43964195, 43968233, 43981293, 43999541, 44010117, 44010465, 44039473, 44056838, 44060132, 44072885, 44073149, 44090669, 44092118, 44094122, 44108545, 44112183, 44117966, 44150897, 44167052, 44168042, 44179750, 44199424, 44225054, 44225258, 44226227, 44226585, 44226654, 44231094, 44233618, 44234803, 44234840, 44237875, 44255648, 44262283, 44262826, 44264102, 44264573, 44265421, 44271391, 44283558, 44287000, 44289115, 44293297, 44303302, 44312782, 44315479, 44327764, 44342010, 44352664, 44372343, 44416667, 44435825, 44438567, 44439898, 44449825, 44450073, 44452220, 44458445, 44460124, 44460749, 44463853, 44466514, 44473363, 44483809, 44486872, 44487784, 44487992, 44488101, 44489681, 44492189, 44492223, 44492252, 44492760, 44492832, 44494129, 44496734, 44497169, 44497196, 44497761, 44497866, 44498576, 44500827, 44500943, 44501037, 44501047, 44501112, 44501201, 44501465, 44501806, 44501832, 44502009, 44502159, 44502179, 44502310, 44502686, 44502718, 44502776, 44502815, 44502943, 44503096, 44508212, 44508273, 44508330, 44508331, 44508358, 44508440, 44508498, 44508645, 44508868, 44509074, 44509520, 44509538, 44511211, 44511231, 44511273, 44511519, 44511573, 44512604, 44513321, 44513358, 44518244, 44518479, 44518497, 44518703, 44518786, 44518917, 44518981, 44519083, 44519095, 44519255, 44519301, 44519307, 44519381, 44519548, 44524967, 44525130, 44525416, 44527324, 44530479, 44530594, 44530719, 44530800, 44531488, 44531803, 44532088, 44534804, 44534900, 44534991, 44535111, 44535241, 44535452, 44535582, 44535643, 44536176, 44536780, 44536823, 44536897, 44538798, 44538819, 44539781, 44539880, 44541779, 44541917, 44548263, 44548530, 44548558, 44548749, 44548825, 44549064, 44549220, 44549413, 44549964, 44550150, 44550234, 44550467, 44550552, 44550575, 44550613, 44550642, 44550675, 44552029, 44552066, 44552865, 44553122, 44554175, 44554259, 44554351, 44554520, 44554837, 44554941, 44555058, 44555261, 44556688, 44557824, 44558175, 44558252, 44558385, 44559077, 44559369, 44559455, 44560001, 44560185, 44561655, 44561903, 44562074, 44562559, 44562662, 44562754, 44563762, 44564474, 44564491, 44571952, 44572025, 44572171, 44572228, 44572357, 44572374, 44572595, 44572865, 44573101, 44573148, 44573485, 44573956, 44574467, 44574766, 44574771, 44574821, 44574929, 44574939, 44575793, 44575871, 44575898, 44576359, 44576647, 44577004, 44577022, 44577116, 44577219, 44578054, 44578080, 44578192, 44578272, 44579036, 44579299, 44579496, 44579697, 44579713, 44579857, 44581304, 44581382, 44583260, 44583657, 44583701, 44584213, 44586462, 44587097, 44587099, 44587181, 44587302, 44587358, 44587899, and 44587976.

Cardiovascular Devices

3

No

Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.

LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

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, 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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, 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44341781, 44341921, 44341977, 44342010, 44342060, 44342141, 44342200, 44342402, 44342701, 44342716, 44349815, 44349890, 44349983, 44350131, 44350171, 44350171, 44350206, 44350230, 44350490, 44350526, 44350563, 44350599, 44350666, 44350879, 44351050, 44351154, 44351197, 44351589, 44354347, 44354377, 44354400, 44354583, 44354674, 44354829, 44354859, 44354963, 44356845, 44356865, 44356913, 44356944, 44357015, 44357018, 44357276, 44358826, 44358830, 44358849, 44358855, 44358860, 44358864, 44358872, 44358902, 44358905, 44358944, 44358969, 44359026, 44359101, 44359140, 44359168, 44360003, 44360132, 44360181, 44360200, 44360258, 44360311, 44361060, 44361121, 44361245, 44361264, 44361330, 44361362, 44361405, 44361418, 44361459, 44361503, 44361533, 44361561, 44361568, 44361594, 44361608, 44361631, 44361636, 44361673, 44361779, 44361811, 44361933, 44361942, 44361978, 44362000, 44362064, 44362249, 44362261, 44362397, 44362422, 44362427, 44362471, 44362474, 44370990, 44371002, 44371014, 44371030, 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Cardiovascular Devices

3

No

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.

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.

Medical electronics / Electromedical devices

Cardiovascular Devices

Medical Device Safety Alert: Physio-Control LIFEPAK 15 Monitor/Defibrillator