LIFEPAK 15 Monitor recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric…

Recalling firm

Physio-Control, Inc.

Quantity

338 units total (US =139 units; International = 199 units)

Distribution

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.

Recall date

February 22, 2017

Classification

Class I

Status

Terminated

Agency

FDA (device)