Class 2 Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)

• Date Initiated by Firm: February 06, 2014
• Date Posted: March 19, 2014
• Recall Status: Terminated on March 23, 2017
• Recall Number: Z-1232-2014
• Recall Event ID: 67612
• 510(K)Number: K020715 K040904
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). ; ; Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads.; ; Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
• Code Information: SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, 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A13G-03683, A13G-03684, A13G-03685, A13G-03686, A13G-03687, A13G-03688, A13G-03689, A13G-03690, A13G-03691, A13G-03692, A13G-03693, A13G-03694, A13G-03695, A13G-03696, A13G-03697, A13G-03698, A13G-03699, A13G-03700, A13G-03701, A13G-03702, A13G-03703, A13G-03704, A13G-03706, A13G-03707, A13G-03708, A13G-03709, A13G-03710, A13G-03711, A13G-03712, A13G-03713, A13G-03714, A13G-03715, A13G-03716, A13G-03717, A13G-03718, A13G-03719, A13G-03720, A13G-03721, A13G-03722, A13G-03723, A13G-03724, A13G-03725, A13G-03726, A13G-03727, A13G-03728, A13G-03730, A13G-03731, A13G-03732, A13G-03733, A13G-03734, A13G-03735, A13G-03737, A13G-03738, A13G-03739, A13G-03740, A13G-03741, A13G-03742, A13G-03743, A13G-03744, A13G-03745, A13G-03746, A13G-03747, A13G-03748, A13G-03749, A13G-03751, A13G-03752, A13G-03753, A13G-03754, A13G-03755, A13G-03756, A13G-03757, A13G-03758, A13G-03759, A13G-03760, A13G-03761, A13G-03762, A13G-03763, A13G-03764, A13G-03765, A13G-03766, A13G-03767, A13G-03768, A13G-03769, A13G-03770, A13G-03771, A13G-03777, A13G-03778, A13G-03779, A13G-03780, A13G-03781, A13G-03782, A13G-03783, A13G-03784, A13G-03785, A13G-03786, A13G-03787, A13G-03788, A13G-03789, A13G-03790, A13G-03791, A13G-03793, A13G-03794, A13G-03795, A13G-03796, A13G-03797, A13G-03798, A13G-03799, A13G-03800, A13G-03801, A13G-03802, A13G-03804, A13G-03805, A13G-03806, A13G-03807, A13G-03808, A13G-03809, A13G-03810, A13G-03811, A13G-03812, A13G-03813, A13G-03814, A13G-03815, A13G-03816, A13G-03817, A13G-03818, A13G-03819, A13G-03820, A13G-03821, A13G-03822, A13G-03823, A13G-03824, A13G-03825, A13G-03826, A13G-03827, A13G-03828, A13G-03829, A13G-03830, A13G-03831, A13G-03832, A13G-03833, A13G-03834, A13G-03835, A13G-03836, A13G-03837, A13G-03838, A13G-03839, A13G-03840, A13G-03841, A13G-03842, A13G-03843, A13G-03844, A13G-03845, A13G-03850, A13G-03852, A13G-03853, A13G-03854, A13G-03855, A13G-03856, A13G-03857, A13G-03858, A13G-03859, A13G-03860, A13G-03861, A13G-03862, A13G-03863, A13G-03864, A13G-03871, A13G-03872, A13G-03874, A13G-03877, A13G-03878, A13G-03879, A13G-03880, A13G-03881, A13G-03882, A13G-03885, A13G-03886, A13G-03887, A13G-03888, A13G-03889, A13G-03890, A13G-03891, A13G-03909, A13G-03911, A13G-03914, A13G-03915, A13G-03916, A13G-03917, A13G-03918, A13G-03923, A13G-03924, A13G-03926, A13G-03927, A13G-03928, A13G-03929, A13G-03931, A13G-03937, A13G-03941, A13G-03943, A13G-03944, A13G-03949, A13G-03953, A13G-03954, A13G-03962, A13G-04029, A13G-04034, A13G-04036, A13G-04049, A13G-04050, A13G-04051, A13G-04056, A13G-04057, A13G-04059, A13G-04062, A13G-04066, A13G-04088, A13G-04089, A13G-04090, A13G-04092, A13G-04115, A13G-04116, A13G-04117, A13G-04118, A13G-04119, A13G-04123, A13G-04124, A13G-04207, A13G-04208, A13G-04209, A13G-04210, A13G-04211, A13G-04212, A13G-04213, A13G-04214, A13G-04220, A13G-04221, A13G-04222, A13G-04223, A13G-04224, A13G-04225, A13G-04227, A13G-04228, A13G-04230, A13G-04232, A13G-04233, A13G-04235, A13G-04238, A13G-04242, A13G-04243, A13G-04244, A13G-04245, A13G-04246, A13G-04247, A13G-04248, A13G-04249, A13G-04250, A13G-04251, A13G-04252, A13G-04256, A13G-04259, A13G-04260, A13G-04261, A13G-04262, A13G-04263, A13G-04264, A13G-04265, A13G-04266, A13G-04267, A13G-04268, A13G-04269, A13G-04270, A13G-04271, A13G-04273, A13G-04282, A13G-04297, A13G-04298, A13G-04299, A13G-04300, A13G-04301, A13G-04302, A13G-04303, A13G-04304, A13G-04305, A13G-04306, A13G-04307, A13G-04308, A13G-04309, A13G-04310, A13G-04311, A13G-04312, A13G-04313, A13G-04314, A13G-04315, A13G-04316, A13G-04317, A13G-04318, A13G-04319, A13G-04320, A13G-04321, A13G-04323, A13G-04324, A13G-04325, A13G-04326, A13G-04332, A13G-04333, A13G-04335, A13G-04336, A13G-04337, A13G-04338, A13G-04339, A13G-04340, A13G-04341, A13G-04342, A13G-04344, A13G-04345, A13G-04346, A13G-04347, A13G-04348, A13G-04349, A13G-04362, A13G-04363, A13G-04364, A13G-04365, A13G-04366, A13G-04369, A13G-04370, A13G-04371, A13G-04372, A13G-04374, A13G-04375, A13G-04376, A13G-04377, A13G-04378, A13G-04379, A13G-04380, A13G-04381, A13G-04382, A13G-04383, A13G-04384, A13G-04385, A13G-04386, A13G-04387, A13G-04388, A13G-04389, A13G-04390, A13G-04391, A13G-04392, A13G-04393, A13G-04394, A13G-04395, A13G-04396, A13G-04397, A13G-04398, A13G-04399, A13G-04401, A13G-04402, A13G-04403, A13G-04404, A13G-04405, A13G-04406, A13G-04407, A13G-04408, A13G-04409, A13G-04410, A13G-04411, A13G-04412, A13G-04414, A13G-04415, A13G-04416, A13G-04417, A13G-04418, A13G-04419, A13G-04421, A13G-04422, A13G-04423, A13G-04424, A13G-04425, A13G-04426, A13G-04427, A13G-04428, A13G-04429, A13G-04430, A13G-04431, A13G-04432, A13G-04433, A13G-04434, A13G-04435, A13G-04436, A13G-04437, A13G-04438, A13G-04439, A13G-04440, A13G-04441, A13G-04442, A13G-04443, A13G-04444, A13G-04445, A13G-04446, A13G-04447, A13G-04448, A13G-04449, A13G-04450, A13G-04451, A13G-04452, A13G-04453, A13G-04454, A13G-04455, A13G-04456, A13G-04457, A13G-04458, A13G-04460, A13G-04462, A13G-04463, A13G-04464, A13G-04465, A13G-04466, A13G-04467, A13G-04468, A13G-04469, A13G-04473, A13G-04474, A13G-04475, A13G-04476, A13G-04477, A13G-04483, A13G-04484, A13G-04485, A13G-04486, A13G-04487, A13G-04488, A13G-04489, A13G-04490, A13G-04491, A13G-04493, A13G-04495, A13G-04496, A13G-04497, A13G-04498, A13G-04501, A13G-04502, A13G-04503, A13G-04504, A13G-04505, A13G-04506, A13G-04507, A13G-04508, A13G-04510, A13G-04511, A13G-04512, A13G-04513, A13G-04514, A13G-04515, A13G-04516, A13G-04517, A13G-04518, A13G-04519, A13G-04520, A13G-04521, A13G-04522, A13G-04525, A13G-04526, A13G-04527, A13G-04528, A13G-04529, A13G-04530, A13G-04531, A13G-04532, A13G-04533, A13G-04534, A13G-04535, A13G-04536, A13G-04537, A13G-04538, A13G-04539, A13G-04540, A13G-04541, A13G-04542, A13G-04543, A13G-04544, A13G-04545, A13G-04546, A13G-04547, A13G-04548, A13G-04549, A13G-04551, A13G-04552, A13G-04553, A13G-04554, A13G-04555, A13G-04556, A13G-04561, A13G-04562, A13G-04563, A13G-04565, A13G-04567, A13G-04568, A13G-04569, A13G-04570, A13G-04571, A13G-04572, A13G-04573, A13G-04574, A13G-04575, A13G-04593, A13G-04594, A13G-04595, A13G-04601, A13G-04602, A13G-04603, A13G-04604, A13G-04605, A13G-04606, A13G-04607, A13G-04609, A13G-04610, A13G-05031, A13G-05034, A13G-05035, A13G-05055, A13G-05057, A13G-05059, A13G-05067, A13G-05068, A13G-05069, A13G-05070, A13G-05071, A13G-05073, A13G-05081, A13G-05082, A13G-05083, A13G-05084, A13G-05085, A13G-05090, A13G-05151, A13G-05152, A13G-05153, A13G-05154, A13G-05155, A13G-05156, A13G-05157, A13G-05158, A13G-05160, A13G-05161, A13G-05162, A13G-05163, A13G-05164, A13G-05165, A13G-05166, A13G-05167, A13G-05168, A13G-05169, A13G-05170, A13G-05171, A13G-05172, A13G-05173, A13G-05174, A13G-05180, A13G-05197, A13G-05198, A13G-05199, A13G-05201, A13G-05202, A13G-05203, A13G-05205, A13G-05212, A13G-05214, A13G-05215, A13G-05218, A13G-05221, A13G-05224, A13G-05225, A13G-05227, A13G-05228, A13G-05229, A13G-05230, A13G-05234, A13G-05235, A13G-05236, A13G-05237, A13G-05238, A13G-05239, A13G-05242, A13G-05246, A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, A13G-05501, A13G-05502, A13G-05503, A13G-05504, A13G-05507, A13G-05520, A13G-05521, A13G-05522, A13G-05524, A13G-05525, A13G-05526, A13G-05527, A13G-05528, A13G-05545, A13G-05550, A13G-05551, A13G-05552, A13G-05555, A13G-05556, A13G-05557, A13G-05558, A13G-05559, A13G-05560, A13G-05561, A13G-05562, A13G-05563, A13G-05564, A13G-05565, A13G-05566, A13G-05567, A13G-05568, A13G-05569, A13G-05570, A13G-05571, A13G-05572, A13G-05573, A13G-05574, A13G-05575, A13G-05576, A13G-05577, A13G-05578, A13G-05589, A13G-05622, A13G-05623, A13G-05624, A13G-05625, A13G-05626, A13G-05627, A13G-05628, A13G-05629, A13G-05630, A13G-05631, A13G-05634, A13G-05635, A13G-05636, A13G-05637, A13G-05638, A13G-05639, A13G-05640, A13G-05642, A13G-05643, A13G-05644, A13G-05645, A13G-05646, A13G-05647, A13G-05648, A13G-05649, A13G-05732, A13G-05733, A13G-05734, A13G-05735, A13G-05736, A13G-05738, A13G-05739, A13G-05740, A13G-05741, A13G-05742, A13G-06169, A13G-06170, A13G-06171, A13G-06174, A13G-06175, A13G-06176, A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-06564, A13G-06566, A13G-06567, A13G-06568, A13G-06569, A13G-06570, A13G-06571, A13G-06572, A13G-06573, A13G-06574, A13G-06575, A13G-06576. SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA: A13G-00066, A13G-00094, A13G-00113, A13G-00191, A13G-00203, A13G-00205, A13G-00206, A13G-00207, A13G-00208, A13G-00209, A13G-00210, A13G-00211, A13G-00212, A13G-00213, A13G-00214, A13G-00216, A13G-00217, A13G-00218, A13G-00219, A13G-00220, A13G-00221, A13G-00224, A13G-00225, A13G-00226, A13G-00227, A13G-00228, A13G-00229, A13G-00230, A13G-00231, A13G-00232, A13G-00233, A13G-00234, A13G-00235, A13G-00236, A13G-00237, A13G-00238, A13G-00239, A13G-00240, A13G-00241, A13G-00242, A13G-00243, A13G-00246, A13G-00247, A13G-00248, A13G-00249, A13G-00250, A13G-00251, A13G-00252, A13G-00253, A13G-00254, A13G-00255, A13G-00256, A13G-00257, A13G-00266, A13G-00267, A13G-00268, A13G-00269, A13G-00270, A13G-00271, A13G-00272, A13G-00273, A13G-00274, A13G-00275, A13G-00276, A13G-00278, A13G-00279, A13G-00280, A13G-00281, A13G-00282, A13G-00283, A13G-00284, A13G-00285, A13G-00286, A13G-00287, A13G-00290, A13G-00291, A13G-00292, A13G-00293, A13G-00295, A13G-00296, A13G-00297, A13G-00298, A13G-00300, A13G-00301, A13G-00302, A13G-00303, A13G-00304, A13G-00305, A13G-00306, A13G-00307, A13G-00308, A13G-00309, A13G-00311, A13G-00312, A13G-00313, A13G-00314, A13G-00315, A13G-00316, A13G-00317, A13G-00318, A13G-00319, A13G-00320, A13G-00321, A13G-00322, A13G-00323, A13G-00324, A13G-00326, A13G-00327, A13G-00328, A13G-00329, A13G-00330, A13G-00332, A13G-00333, A13G-00334, A13G-00335, A13G-00346, A13G-00347, A13G-00348, A13G-00349, A13G-00350, A13G-00351, A13G-00352, A13G-00354, A13G-00358, A13G-00360, A13G-00361, A13G-00362, A13G-00363, A13G-00364, A13G-00365, A13G-00366, A13G-00367, A13G-00368, A13G-00369, A13G-00370, A13G-00371, A13G-00372, A13G-00373, A13G-00374, A13G-00382, A13G-00383, A13G-00384, A13G-00385, A13G-00387, A13G-00388, A13G-00390, A13G-00391, A13G-00392, A13G-00393, A13G-00394, A13G-00395, A13G-00396, A13G-00397, A13G-00399, A13G-00401, A13G-00402, A13G-00405, A13G-00411, A13G-00412, A13G-00413, A13G-00414, A13G-00416, A13G-00422, A13G-00424, A13G-00425, A13G-00426, A13G-00427, A13G-00428, A13G-00429, A13G-00430, A13G-00431, A13G-00432, A13G-00433, A13G-00434, A13G-00437, A13G-00438, A13G-00440, A13G-00441, A13G-00442, A13G-00443, A13G-00445, A13G-00446, A13G-00447, A13G-00467, A13G-00471, A13G-00472, A13G-00473, A13G-00474, A13G-00475, A13G-00476, A13G-00479, A13G-00480, A13G-00481, A13G-00482, A13G-00483, A13G-00484, A13G-00486, A13G-00487, A13G-00488, A13G-00489, A13G-00491, A13G-00492, A13G-00494, A13G-00504, A13G-00505, A13G-00506, A13G-00507, A13G-00508, A13G-00510, A13G-00512, A13G-00515, A13G-00516, A13G-00517, A13G-00518, A13G-00519, A13G-00520, A13G-00521, A13G-00522, A13G-00523, A13G-00524, A13G-00525, A13G-00526, A13G-00527, A13G-00528, A13G-00530, A13G-00531, A13G-00532, A13G-00533, A13G-00534, A13G-00535, A13G-00536, A13G-00537, A13G-00538, A13G-00539, A13G-00540, A13G-00541, A13G-00542, A13G-00543, A13G-00544, A13G-00545, A13G-00546, A13G-00547, A13G-00548, A13G-00549, A13G-00550, A13G-00551, A13G-00553, A13G-00556, A13G-00558, A13G-00566, A13G-00567, A13G-00568, A13G-00571, A13G-00574, A13G-00578, A13G-00579, A13G-00580, A13G-00581, A13G-00582, A13G-00583, A13G-00584, A13G-00585, A13G-00586, A13G-00587, A13G-00589, A13G-00590, A13G-00591, A13G-00592, A13G-00593, A13G-00594, A13G-00595, A13G-00596, A13G-00598, A13G-00599, A13G-00602, A13G-00603, A13G-00604, A13G-00605, A13G-00606, A13G-00607, A13G-00608, A13G-00609, A13G-00616, A13G-00618, A13G-00625, A13G-00628, A13G-00629, A13G-00632, A13G-00634, A13G-00636, A13G-00638, A13G-00640, A13G-00641, A13G-00642, A13G-00644, A13G-00645, A13G-00646, A13G-00647, A13G-00648, A13G-00649, A13G-00650, A13G-00651, A13G-00652, A13G-00654, A13G-00655, A13G-00656, A13G-00657, A13G-00665, A13G-00666, A13G-00667, A13G-00668, A13G-00670, A13G-00671, A13G-00672, A13G-00673, A13G-00675, A13G-00684, A13G-00700, A13G-00701, A13G-00702, A13G-00703, A13G-00704, A13G-00708, A13G-00709, A13G-00711, A13G-00718, A13G-00720, A13G-00721, 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A13G-05146, A13G-05147, A13G-05148, A13G-05149, A13G-05150, A13G-05159, A13G-05175, A13G-05181, A13G-05182, A13G-05184, A13G-05185, A13G-05186, A13G-05187, A13G-05188, A13G-05192, A13G-05193, A13G-05194, A13G-05195, A13G-05207, A13G-05208, A13G-05209, A13G-05210, A13G-05211, A13G-05213, A13G-05220, A13G-05222, A13G-05226, A13G-05231, A13G-05232, A13G-05241, A13G-05249.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Inc.; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: 800-263-3342 Ext. 5
• Manufacturer Reason for Recall: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
• FDA Determined Cause: Vendor change control
• Action: Philips began sending out the Urgent Medical Device Recall HeartStart Home and OnSite (HS1) letter, dated 2014 FEB 10, to consignees on 2/17/14. The letter identified the product, the problem, and the action to be taken by the customer. Customers are advised to contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. Customers can also leave a message 24 hours a day, seven days a week. DISTRIBUTORS are instructed to provide Philips with the information provided in the letter. Customers who have an affected device will be supplied with a replacement AED from Philips, free of charge. If customers/distributors need any further information or support concerning this issue, please visit www.philips.com/HeartStartHS1PinAction.
• Quantity in Commerce: 5075 units total (2724 units in the US and 2351 units outside the US)
• Distribution: Worldwide Distribution - USA Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS