Philips Diagnostic Ultrasound System

All HDI4000 Systems in distribution are affected. Serial Part: A1C000003, A21000009, A21000010, A21000011, A21000012, A21000013, A21000015, A21000016, A21000017, A21000018, A21000019, A21000020, A21000021, A21000022, A21000023, A21000024, A21000026, A21000027, A21000028, A21000029, A21000030, A21000032, A21000033, A21000034, A21000035, A21000036, A21000037, A21000039, A23000040, A23000041, A23000042, A23000043, A23000044, A23000045, A23000046, A23000047, A23000048, A23000050, A24000051, A24000052, A24000054, A24000055, A24000056, A24000057, A24000058, A24000060, A24000061, A24000063, A24000064, A24000065, A24000066, A24000067, A24000068, A24000070, A24000071, A24000072, A24000073, A24000074, A24000075, A24000076, A24000077, A24000078, A24000079, A24000080, A24000081, A24000082, A24000083, A24000084, A24000085, A24000086, A24000087, A24000088, A24000089, A24000091, A24000092, A24000093, A24000094, A24000095, A24000096, A24000097, A24000098, A24000100, A24000101, A24000102, A24000103, A24000104, A24000105, A25000106, A25000107, A25000108, A25000110, A25000112, A25000113, A25000114, A25000115, A25000116, A25000117, A25000118, A25000119, A25000120, A25000121, A25000122, A25000123, A25000124, A25000125, A25000126, A25000127, A25000128, A25000129, A25000130, A25000131, A25000132, A25000133, A25000134, A25000135, A25000137, A25000138, A25000139, A25000140, A25000142, A25000143, A25000144, A25000145, A25000146, A25000147, A25000148, A25000149, A25000150, A25001682, A26000151, A26000152, A26000153, A26000153, A26000154, A26000155, A26000156, A26000157, A26000158, A26000159, A26000160, A26000162, A26000163, A26000164, A26000165, A26000166, A26000168, A26000169, A26000170, A26000171, A26000172, A26000173, A26000174, A26000175, A26000176, A26000177, A26000178, A26000179, A26000180, A26001694, A26001696, A26001698, A26001700, A27000181, A27000182, A27000183, A27000184, A27000185, A27000186, A27000187, A27000188, A27000189, A27000190, A27000191, A27000192, A27000194, A27000195, A27000196, A27000197, A27000198, A27000199, A27000200, A27000201, A27000202, A27000203, A27000204, A27000205, A27000206, A27000207, A27000208, A27000209, A27000210, A27000211, A27000212, A27000213, A27000215, A28000216, A28000217, A28000218, A28000219, A28000220, A28000221, A28000222, A28000223, A28000224, A28000225, A28000226, A28000227, A28000228, A28000229, A28000230, A28000231, A28000232, A28000233, A28000234, A28000235, A28000236, A28000237, A28000238, A28000239, A28000240, A28000241, A28000242, A28000243, A28000244, A28000245, A28000246, A28000248, A28000249, A28000250, A28000251, A28000252, A28000253, A28000254, A28000255, A28000256, A28000257, A28000258, A28000259, A28000260, A28000261, A28000262, A28000264, A28000265, A28000265, A28000267, A28000268, A28000269, A28000270, A28000271, A28000272, A28000273, A28000274, A28000275, A28000276, A28000277, A28000278, A28000279, A28000280, A28000281, A28000282, A28000283, A28000284, A28000285, A28000307, A29000286, A29000287, A29000288, A29000289, A29000290, A29000291, A29000292, A29000293, A29000294, A29000295, A29000296, A29000297, A29000298, A29000299, A29000300, A29000302, A29000303, A29000304, A29000305, A29000306, A29000307, A29000308, A29000309, A29000310, A29000311, A29000312, A29000313, A29000314, A29000315, A29000316, A29000317, A29000318, A29000319, A29000320, A29000321, A29000322, A29000323, A29000324, A29000325, A2A000326, A2A000327, A2A000328, A2A000329, A2A000330, A2A000331, A2A000332, A2A000333, A2A000334, A2A000335, A2A000336, A2A000337, A2A000338, A2A000339, A2A000340, A2A000342, A2A000344, A2A000345, A2A000345A, A2A000346, A2A000347, A2A000348, A2A000349, A2A000350, A2A000351, A2A000352, A2A000353, A2A000354, A2A000355, A2B000356, A2B000357, A2B000358, A2B000359, A2B000360, A2B000361, A2B000362, A2B000363, A2B000364, A2B000365, A2B000366, A2B000367, A2B000368, A2B000369, A2B000370, A2B000371, A2B000372, A2B000373, A2B000374, A2B000375, A2B000376, A2B000377, A2B000379, A2B000380, A2B000381, A2B000382, A2B000384, A2B000385, A2B000386, A2B000387, A2B000388, A2B000389, A2B000390, A2B000391, A2B000392, A2B000393, A2B000394, A2B000395, A2B000396, A2B000397, A2B000398, A2B000399, A2B000400, A2B000401, A2B000402, A2B000403, A2B000404, A2B000405, A2B000406, A2B000407, A2B000408, A2B000409, A2B000410, A2B000411, A2B000412, A2B000413, A2B000414, A2B000415, A2B000416, A2B000417, A2B000418, A2B000419, A2B000420, A2B000421, A2B000422, A2B000423, A2B000424, A2B000425, A2B000426, A2B000427, A2B000428, A2B000429, A2B000430, A2B000431, A2B000432, A2B000433, A2B000434, A2B000435, A2C000436, A2C000437, A2C000438, A2C000439, A2C000440, A2C000441, A2C000442, A2C000443, A2C000444, A2C000445, A2C000446, A2C000447, A2C000448, A2C000449, A2C000450, A2C000451, A2C000452, A2C000454, A2C000455, A2C000456, A2C000457, A2C000458, A2C000459, A2C000460, A2C000461, A2C000462, A2C000463, A2C000464, A2C000465, A31000466, A31000467, A31000468, A31000469, A31000470, A31000471, A31000473, A31000474, A31000475, A31000477, A31000478, A31000479, A31000480, A31000481, A31000482, A31000485, A31000486, A31000487, A31000488, A31000489, A31000491, A31000492, A31000493, A31000494, A32000483, A32000490, A32000495, A32000496, A32000497, A32000498, A32000499, A32000500, A32000501, A32000502, A32000503, A32000504, A32000505, A32000506, A32000507, A32000509, A32000510, A32000512, A32000513, A32000514, A32000515, A32000516, A32000517, A32000518, A32000519, A33000520, A33000521, A33000522, A33000523, A33000524, A33000525, A33000526, A33000527, A33000528, A33000529, A33000530, A33000531, A33000532, A33000533, A33000534, A33000535, A33000536, A33000537, A33000538, A33000539, A33000540, A33000541, A33000542, A33000543, A33000544, A33000545, A33000546, A33000547, A33000548, A33000549, A33000550, A33000551, A33000552, A33000553, A34000555, A34000556, A34000557, A34000558, A34000559, A34000560, A34000561, A34000562, A34000563, A34000564, A34000565, A34000566, A34000567, A34000568, A34000569, A34000570, A34000571, A34000572, A34000573, A34000574, A34000575, A34000576, A34000577, A34000578, A34000579, A34000580, A34000581, A34000582, A34000583, A34000584, A34000585, A34000586, A34000587, A34000588, A34000589, A34000590, A34000591, A34000592, A34000592, A34000593, A34000594, A34000595, A34000597, A34000598, A34000599, A34000600, A34000601, A34000602, A34000603, A34000604, A34000605, A34000607, A34000608, A34000609, A34000610, A34000611, A34000612, A34000613, A34000614, A34000615, A34000616, A34000617, A34000618, A34000619, A34000620, A34000621, A34000622, A34000623, A34000624, A34000625, A34000626, A34000627, A34000628, A34000629, A35000630, A35000631, A35000632, A35000633, A35000634, A35000635, A35000636, A35000637, A35000638, A35000640, A35000641, A35000642, A35000643, A35000644, A35000645, A35000646, A35000647, A35000648, A35000649, A35000650, A35000651, A35000652, A35000653, A35000654, A35000655, A35000656, A35000657, A35000658, A35000659, A35000660, A35000661, A35000662, A35000663, A35000664, A35000665, A35000666, A35000667, A35000668, A35000669, A36000670, A36000671, A36000672, A36000673, A36000674, A36000675, A36000676, A36000677, A36000678, A36000679, A36000680, A36000681, A36000682, A36000683, A36000684, A36000685, A36000686, A36000687, A36000688, A36000689, A36000690, A36000691, A36000692, A36000693, A36000694, A36000695, A36000696, A36000697, A36000698, A36000699, A36000700, A36000701, A36000702, A36000703, A36000704, A36000705, A36000706, A36000707, A36000708, A36000709, A36000710, A36000711, A36000712, A36000713, A36000714, A36000715, A36000716, A36000717, A36000718, A36000719, A37000720, A37000721, A37000722, A37000723, A37000724, A37000725, A37000726, A37000727, A37000728, A37000729, A37000730, A37000731, A37000732, A37000733, A37000734, A37000735, A37000736, A37000737, A37000738, A37000739, A37000740, A37000741, A37000742, A37000743, A37000744, A38000745, A38000746, A38000747, A38000748, A38000749, A38000750, A38000751, A38000752, A38000753, A38000754, A38000755, A38000756, A38000757, A38000758, A38000759, A38000760, A38000761, A38000762, A38000763, A38000764, A39000765, A39000766, A39000767, A39000768, A39000769, A39000770, A39000771, A39000772, A39000773, A39000774, A39000775, A39000776, A39000777, A39000778, A39000779, A39000780, A39000781, A39000782, A39000783, A39000784, A39000785, A39000786, A39000787, A39000788, A39000789, A3B000790, A3B000791, A3B000792, A3B000793, A3B000794, A3B000795, A3B000796, A3B000797, A3B000799, A3B000800, A3B000801, A3B000802, A3B000803, A3B000804, A3B000805, A3B000806, A3B000807, A3B000808, A3B000809, A3C000810, A3C000811, A3C000812, A3C000813, A3C000814, A3C000815, A3C000816, A3C000817, A3C000818, A3C000819, A3C000820, A3C000821, A3C000822, A3C000823, A3C000824, A3C000825, A3C000826, A3C000827, A3C000828, A3C000829, A3C000830, A3C000831, A3C000832, A3C000833, A3C000834, A3C000835, A3C000836, A3C000837, A3C000838, A3C000839, A3C000840, A3C000841, A3C000842, A3C000843, A3C000844, A3C000845, A3C000846, A3C000847, A3C000848, A3C000849, A3C000850, A3C000851, A3C000852, A3C000853, A3C000854, A41000855, A41000856, A41000857, A41000858, A41000859, A41000860, A41000861, A41000862, A41000863, A41000864, A41000865, A41000866, A41000867, A41000868, A41000869, A41000870, A41000871, A41000872, A41000873, A41000874, A41000875, A41000876, A41000877, A41000878, A41000879, A42000880, A42000881, A42000882, A42000883, A42000884, A42000885, A42000886, A42000887, A42000888, A42000889, A42000890, A42000891, A42000892, A42000893, A42000894, A42000895, A42000896, A42000897, A42000898, A42000899, A42000900, A42000901, A42000902, A42000903, A42000904, A42000905, A42000906, A42000907, A42000908, A42000909, A42000910, A42000911, A42000912, A42000913, A42000914, A42000915, A42000916, A42000917, A42000918, A42000919, A42000920, A42000921, A42000922, A42000923, A42000924, A42000925, A42000926, A42000927, A42000928, A42000929, A42000930, A42000931, A42000932, A42000933, A42000934, A42000935, A42000936, A42000937, A42000938, A42000939, A42000940, A42000941, A42000942, A42000943, A42000944, A42000945, A42000946, A42000947, A42000948, A42000949, A42000950, A42000951, A42000952, A42000953, A42000954, A42000955, A42000956, A42000957, A42000958, A42000959, A42000960, A42000961, A42000962, A42000963, A42000964, A42000965, A42000966, A42000967, A42000968, A42000969, A43000970, A43000971, A43000972, A43000973, A43000974, A43000975, A43000976, A43000977, A43000978, A43000979, A43000980, A43000981, A43000982, A43000983, A43000984, A43000985, A43000986, A43000987, A43000988, A43000989, A43000990, A43000991, A43000992, A43000993, A43000994, A43000995, A43000996, A43000997, A43000998, A43000999, A43001000, A43001001, A43001002, A43001003, A43001004, A43001005, A43001006, A43001007, A43001008, A43001010, A43001011, A43001012, A43001013, A43001014, A44001015, A44001016, A44001017, A44001018, A44001019, A44001020, A44001021, A44001022, A44001023, A44001024, A44001025, A44001026, A44001027, A44001028, A44001029, A44001030, A44001031, A44001032, A44001034, A44001035, A44001036, A44001037, A44001038, A44001039, A44001040, A44001041, A44001042, A44001043, A44001044, A44001045, A44001046, A44001047, A44001048, A44001049, A45001033, A45001050, A45001051, A45001052, A45001053, A45001054, A45001055, A45001056, A45001057, A45001058, A45001059, A45001060, A45001061, A45001062, A45001063, A45001064, A45001065, A45001066, A45001067, A45001068, A45001069, A45001070, A45001071, A45001072, A45001073, A45001074, A45001075, A45001076, A45001077, A45001078, A45001079, A45001080, A45001081, A45001082, A45001083, A45001084, A45001085, A45001086, A45001087, A45001088, A45001089, A45001090, A45001091, A45001092, A45001093, A45001094, A45001095, A45001096, A45001098, A45001099, A45001100, A45001101, A45001102, A45001103, A45001104, A45001105, A45001106, A45001107, A45001108, A45001109, A45001110, A45001111, A45001112, A45001113, A45001114, A45001115, A45001116, A45001117, A45001118, A45001119, A45001120, A45001121, A45001122.A45001123, A45001124, A46001097, A46001125, A46001126, A46001127, A46001128, A46001129, A46001130, A46001131, A46001132, A46001133, A46001134, A46001135, A46001136, A46001137, A46001138, A46001139, A46001140, A46001141, A46001142, A46001143, A46001144, A46001145, A46001146, A46001147, A46001148, A46001149, A46001150, A46001151, A46001152, A46001153, A46001154, A46001155, A46001156, A46001157, A46001158, A46001159, A46001160, A46001161, A46001162, A46001163, A46001164, A46001165, A46001166, A46001167, A46001168, A46001169, A46001170, A46001171, A46001172, A46001173, A46001174, A46001175, A46001176, A46001177, A46001178, A46001179, A46001180, A46001181, A46001182, A46001183, A46001184, A46001185, A46001186, A46001187, A46001188, A46001189, A46001190, A46001191, A46001192, A46001193, A46001194, A46001195, A46001196, A46001197, A46001198, A46001199, A47001200, A47001201, A47001202, A47001203, A47001204, A47001205, A47001206, A47001207, A47001208, A47001209, A47001210, A47001211, A47001212, A47001213, A47001214, A47001215, A47001216, A47001217, A47001218, A47001219, A47001220, A47001221, A47001222, A47001223, A47001224, A47001225, A47001226, A47001227, A47001228, A47001229, A47001230, A47001231, A47001232, A47001233, A47001234, A47001235, A47001236, A47001237, A47001238, A47001239, A47001240, A47001241, A47001242, A47001243, A47001244, A47001245, A47001246, A47001247, A47001248, A47001249, A47001250, A47001251, A47001252, A47001253, A47001254, A47001255, A47001256, A47001257, A47001258, A47001259, A47001260, A47001261, A47001262, A47001263, A47001264, A47001265, A47001266, A47001267, A47001268, A47001269, A48001270, A48001271, A48001272, A48001273, A48001274, A48001275, A48001276, A48001277, A48001278, A48001279, A48001280, A48001281, A48001282, A48001283, A48001284, A48001285, A48001286, A48001287, A48001288, A48001289, A48001290, A48001291, A48001292, A48001293, A48001294, A48001295, A48001296, A48001297, A48001298, A48001299, A48001300, A48001301, A48001302, A48001303, A48001304, A48001305, A48001306, A48001307, A48001308, A48001309, A49001310, A49001311, A49001312, A49001313, A49001314, A49001315, A49001316, A49001317, A49001318, A49001319, A49001320, A49001321, A49001322, A49001323, A49001324, A49001325, A49001326, A49001327, A49001328, A49001329, A49001330, A49001331, A49001332, A49001333, A49001334, A49001335, A49001336, A49001337, A49001338, A49001339, A49001341, A49001342, A49001343, A49001344, A4A001345, A4A001346, A4A001348, A4A001349, A4A001352, A4A001353, A4A001354, A4A001355, A4A001356, A4A001357, A4A001358, A4A001359, A4A001360, A4A001361, A4A001362, A4A001363, A4A001364, A4B001365, A4B001366, A4B001367, A4B001369, A51001370, A51001371, A51001372, A51001373, A51001374, A51001375, A51001376, A51001377, A51001378, A51001379, A51001381, A51001382, A51001383, A51001384, A51001385, A51001386, A51001387, A51001389, A51001392, A51001393, A51001394, A51001395, A51001396, A51001397, A51001398, A51001399, A52001400, A52001401, A52001402, A52001403, A52001404, A52001405, A52001406, A52001407, A52001408, A52001409, A52001410, A52001411, A52001412, A52001414, A52001415, A52001416, A52001417, A52001418, A52001419, A52001420, A57504300000009, A57504300000010, A57504300000011, A57504300000012, A57504300000013, A57504300000014, A57504300000015, A57504300000016, A57504300000017, A57504300000018, A57504300000019, A57504300000020, A57504300000021, A57504300000022, A57504300000023, A57504300000024, A57504300000025, A57504300000026, A57504300000027, A57504300000028, A57504300000029, A57504300000030, A57504300000031, A57504300000032, A57504300000033, A57504300000034, A57504300000035, A57504300000036, A57504300000037, A57504300000038, A57504300000039, A57504300000040, A57504300000041, A57504300000042, A57504300000043, A57504300000044, A57504300000045, A57504300000046, A57504300100014, A58504300000047, A58504300000048, A58504300000049, A58504300000050, A58504300000051, A58504300000052, A58504300000053, A58504300000054, A58504300000055, A58504300000056, A58504300000057, A58504300000058, A58504300000059, A58504300000060, A58504300000061, A58504300000062, A58504300000063, A58504300000064, A58504300000065, A58504300000066, A58504300000067, A58504300000068, A58504300000069, A58504300000070, A58504300000071, A58504300000072, A58504300000073, A58504300000074, A58504300000075, A58504300000076, A58504300000077, A58504300000078, A58504300000079, A58504300000080, A58504300000081, A58504300000082, A58504300000083, A58504300000084, A58504300000085, A58504300000086, A58504300000087, A58504300000088, A58504300000089, A58504300000090, A58504300000091, A58504300000092, A58504300000093, A58504300000094, A58504300000095, A58504300000096, A58504300000097, A58504300000098, A58504300000099, A58504300000100, A58504300000101, A58504300000102, A58504300000103, A58504300000104, A58504300000105, A58504300000106, A58504300000107, A58504300000128, A58504300000129, A58504300000130, A58504300000131, A58504300000132, A58504300000133, A58504300000134, A58504300000135, A58504300000136, 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Radiology Devices

2

No

Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).

Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL' and labeled, "Distributed by ATL Ultrasound Bothell, WA. USA 98041"; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. || Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.