Philips Ultrasound, Inc. Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)
Brand
Philips Ultrasound, Inc.
Lot Codes / Batch Numbers
Serial numbers for domestic units: A21000015, A21000016, A21000018, A23000040, A23000042, A23000047, A24000051, A24000052, A24000054, A24000055, A24000056, A24000057, A24000060, A24000061, A24000067, A24000073, A24000076, A24000077, A24000084, A24000087, A24000096, A24000101, A24000104, A25000106, A25000108, A25000110, A25000115, A25000116, A25000118, A25000126, A25000130, A25000131, A25000133, A25000136, A25000137, A25000143, A25000144, A25000145, A25000146, A25000147, A25000148, A26000153, A26000154, A26000157, A26000159, A26000160, A26000161, A26000164, A26000165, A26000167, A26000170, A26000171, A26000173, A26000176, A26000178, A26000179, A26000180, A27000181, A27000184, A27000186, A27000188, A27000189, A27000192, A27000194, A27000197, A27000198, A27000200, A27000202, A27000203, A27000204, A27000210, A27000211, A27000212, A28000220, A28000226, A28000229, A28000230, A28000231, A28000235, A28000238, A28000241, A28000243, A28000247, A28000250, A28000253, A28000255, A28000257, A28000260, A28000262, A28000265, A28000267, A28000270, A28000273, A28000275, A28000276, A28000277, A28000280, A28000281, A29000289, A29000290, A29000292, A29000300, A29000310, A29000318, A29000319, A29000323, A29000325, A2A000327, A2A000330, A2A000335, A2A000337, A2A000338, A2A000340, A2A000344, A2A000345, A2A000348, A2A000349, A2A000350, A2A000353, A2A000354, A2B000358, A2B000365, A2B000372, A2B000374, A2B000381, A2B000385, A2B000395, A2B000399, A2B000408, A2B000411, A2B000420, 2C000437, A2C000438, A2C000439, A2C000440, A2C000441, 2C000443, A2C000444, A2C000445, A2C000446, A2C000447, 2C000448, A2C000449, A2C000450, A2C000451, A2C000452, 2C000455, A2C000456, A2C000457, A2C000458, A2C000459, 2C000460, A2C000462, A2C000463, A2C000465, A31000466, 31000467, A31000468, A31000470, A31000474, A31000475, A31000477, A31000478, A31000479, A31000480, A31000481, A31000482, A31000488, A31000489, A31000491, A31000492, A31000493, A32000483, A32000490, A32000495, A32000498, A32000499, A32000501, A32000502, A32000505, A32000507, A32000509, A32000513, A32000515, A32000516, A32000517, A33000523, A33000528, A33000534, A33000536, A33000540, A33000546, A33000549, A33000550, A34000556, A34000557, A34000559, A34000560, A34000563, A34000565, A34000567, A34000568, A34000577, A34000578, A34000582, A34000587, A34000588, A34000589, A34000595, A34000596, A34000597, A34000599, A34000603, A34000606, A34000607, A34000611, A34000612, A34000614, A34000615, A34000616, A34000621, A34000623, A34000627, A34000628, A34000629, A35000630, A35000636, A35000637, A35000641, A35000642, A35000643, A35000644, A35000645, A35000649, A35000650, A35000652, A35000654, A35000659, A35000663, A35000664, A35000665, A35000669, A36000670, A36000674, A36000677, A36000678, A36000687, A36000692, A36000694, A36000702, A36000705, A36000706, A36000707, A36000716, A36000717, A37000720, A37000721, A37000723, A37000732, A37000735, A37000736, A37000738, A37000743, A38000753, A38000756, A38000760, A39000767, A39000769, A39000776, A39000778, A39000780, A39000783, A3B000790, A3B000794, A3B000796, A3B000799, A3B000802, A3B000804, A3B000806, A3C000812, A3C000813, 3C000824, A3C000825, A3C000826, A3C000846, A3C000850, 3C000853, A3C000854, A41000858, A41000861, A41000865, A41000869, A41000872, A41000873, A42000885, A42000887, A42000889, A42000891, A42000892, A42000893, A42000894, A42000895, A42000896, A42000897, A42000898, A42000899, A42000901, A42000903, A42000906, A42000907, A42000912, A42000913, A42000916, A42000921, A42000922, A42000925, A42000928, A42000931, A42000932, A42000934, A42000941, A42000945, A42000947, A42000952, A42000959, A43000980, A43000982, A43000995, A43001003, A43001005, A43001006, A44001017, A44001018, A44001019, A44001022, A44001026, A44001027, A44001028, A44001032, A44001038, A44001045, A45001050, A45001051, A45001053, A45001058, A45001061, A45001066, A45001073, A45001077, A45001084, A45001089, A45001100, A45001104, A45001106, A45001112, A45001117, A46001125, A46001133, A46001142, A46001143, A46001144, A46001157, A46001160, A46001177, A46001184, A46001193, A46001198, A47001201, A47001208, A47001219, A47001225, A47001230, A47001235, A47001237, A47001245, A47001247, A47001250, A47001253, A47001259, A48001271, A48001282, A48001283, A48001284, A48001288, A48001290, A48001294, A48001295, A49001312, A49001313, A49001327, A49001341, A4A001347, A4A001353, A4A001357, A51001373, A51001383, 51001389. Serial Numbers for Foreign Units: A21000034, A23000045, A34000569, A39000766, A42000956, A45001052, A45001062, A46001147, A47001213, A47001255, A47001260, A48001285, A49001333, A52001402, A58504300000054, A58504300000060, A58504300000065, A58504300000073, A58504300000081, A58504300000137, A58504300000141, A21000033, A25000139, A27000187, A36000710, A44001029, A44001030, A46001152, A46001187, A23000044, A28000221, A42000930, A43001014, A45001085, A45001103, A46001148, A46001166, A46001188, A47001221, A47001241, A47001248, A47001265, A57504300000012, A5A504300000177, A5A504300000185, A24000083, A26000158, A26000166, A34000592, A34000592, A35000667, A38000761, A3C000818, A3C000841, A41000879, A46001130, A46001196, A47001200, A47001246, A2A000346, A21000017, A21000028, A24000089, A24000098, A27000207, A28000269, A28000271, A28000284, A32000497, A33000524, A33000527, A34000574, A34000581, A36000695, A36000700, A37000742, A3B000791, A3B000795, A3C000829, A42000900, A42000902, A42000964, A43001000, A44001015, A45001078, A45001094, A45001108, A45001113, A46001129, A46001153, A46001161, A46001168, A46001169, A46001170, A46001173, A46001174, A46001189, A51001378, A52001406, A58504300000055, A58504300000072, A58504300000075, A58504300000080, A58504300000094, A58504300000101, A58504300000105, A23000043, A24000063, A24000088, A24000095, A24000097, A24000100, A25000114, A25000121, A25000150, A36000681, A46001183, A26000156, A45001088, A26000162, A1C000003, A28000252, A2A000332, A2A000334, A31000486, A32000506, A25000142, A28000216, A28000222, A34000591, A42000949, A21000024, A23000046, A24000070, A24000102, A26000169, A26000172, A28000217, A28000278, A29000298, A29000308, A31000469, A34000579, A34000586, A34000605, A34000624, A39000785, A44001034, A45001092, A46001164, A47001212, A47001257, A48001300, A49001322, A49001331, A51001385, A51001395, A21000022, A21000023, A23000041, A23000048, A24000071, A24000074, A24000079, A24000091, A24000092, A25000120, A25000129, A25000138, A27000183, A27000191, A27000201, A27000205, A27000209, A28000223, A28000228, A28000233, A28000236, A28000249, A28000254, A28000258, A28000272, A28000282, A28000307, A29000286, A29000295, A29000296, A29000299, A29000302, A29000303, A29000305, A29000307, A29000320, A29000321, A2A000328, A2A000336, A2A000339, A2A000352, A2A000355, A2B000413, A2B000414, A2B000417, A2B000422, A2B000424, A2B000434, A2B000435, A2C000454, A31000487, A32000496, A32000514, A32000519, A33000543, A33000545, A33000551, A33000552, A34000585, A34000593, A34000601, A34000604, A34000618, A34000620, A34000625, A34000626, A35000631, A35000635, A35000640, A36000676, A36000683, A38000763, A39000771, A39000772, A39000774, A39000781, A3B000809, A3C000817, A3C000819, A3C000820, A3C000828, A3C000834, A42000914, A42000933, A44001049, A45001054, A45001082, A45001086, A46001097, A46001151, A46001180, A46001190, A46001199, A47001206, A47001216, A47001236, A47001239, A47001244, A47001249, A47001268, A48001274, A48001301, A4A001356, A4B001369, A51001376, A51001377, A51001379, A51001384, A52001407, A52001412, A52001414, A52001417, A52001419, A57504300000011, A57504300000017, A57504300000034, A58504300000048, A58504300000049, A58504300000058, A58504300000063, A58504300000067, A58504300000068, A58504300000069, A58504300000084, A58504300000089, A58504300000096, A58504300000102, A58504300000106, A58504300000128, A58504300000132, A58504300000133, A58504300000134, A58504300000145, A58504300000146, A58504300000147, A59504300000154, A59504300000161, A59504300000162, A59504300000166, A59504300000169, A59504300000171, A5A504300000172, A5A504300000181, A5A504300000197, A5A504300000200, A5A504300000210, A5A504300000211, A25000119, A2B000398, A34000570, A35000668, A36000675, A3C000811, A43000973, A43000983, A46001158, A21000029, A24000064, A24000065, A24000072, A24000075, A24000105, A27000182, A27000213, A28000224, A28000232, A28000240, A28000268, A29000322, A2A000326, A2A000347, A2B000357, A2B000363, A2B000393, A2B000421, A2C000461, A31000485, A32000503, A33000533, A33000539, A33000541, A33000544, A33000548, A33000553, A34000564, A34000571, A35000638, A35000653, A36000673, A36000699, A36000701, A37000725, A37000728, A37000730, A38000755, A38000758, A39000786, A3B000803, A3C000835, A3C000837, A3C000845, A41000878, A42000881, A42000886, A43000985, A43000999, A44001016, A44001036, A44001044, A45001055, A45001059, A45001081, A45001083, A45001095, A45001107, A45001109, A45001111, A45001114, A45001115, A45001116, A45001118, A45001123, A46001134, A46001156, A46001194, A46001197, A47001215, A47001227, A47001231, A47001232, A47001242, A47001251, A47001261, A47001262, A47001264, A47001266, A48001270, A48001286, A48001291, A48001303, A49001325, A49001326, A49001328, A4A001346, A4A001348, A4A001352, A4A001354, A4A001359, A4A001360, A4A001361, A4A001363, A4A001364, A4B001366, A51001370, A52001400, A52001401, A52001404, A52001408, A52001409, A52001411, A52001415, A52001418, A57504300000009, A57504300000037, A58504300000050, A58504300000052, A58504300000071, A58504300000077, A58504300000079, A58504300000086, A58504300000091, A58504300000095, A58504300000100, A58504300000129, A58504300000130, A58504300000131, A58504300000135, A58504300000136, A58504300000138, A58504300000139, A58504300000142, A58504300000144, A59504300000150, A59504300000155, A59504300000156, A59504300000158, A59504300000159, A59504300000170, A5A504300000176, A5A504300000178, A5A504300000179, A5A504300000182, A5A504300000183, A5A504300000188, A5A504300000189, A28000234, A24000068, A27000206, A28000259, A28000261, A28000264, A28000279, A29000309, A29000312, A29000314, A29000315, A2B000397, A2B000407, A35000655, A35000666, A36000711, A36000712, A36000714, A37000724, A37000727, A3C000816, A42000888, A43000971, A43000974, A43000984, A43000986, A43000989, A43000991, A43001002, A44001040, A45001057, A45001065, A46001182, A47001205, A47001224, A48001297, A48001304, A49001332, A57504300000029, A59504300000160, A5A504300000194, A21000009, A21000035, A33000522, A34000609, A34000622, A47001240, A21000026, A24000059, A24000078, A27000208, A28000227, A28000239, A28000244, A28000246, A29000291, A29000294, A29000297, A29000304, A29000306, A29000311, A29000313, A2A000351, A2B000364, A31000494, A33000525, A33000529, A33000547, A34000566, A34000575, A35000651, A35000661, A36000679, A36000680, A36000708, A3B000800, A3B000807, A3B000808, A3C000815, A3C000848, A41000877, A42000909, A42000911, A42000919, A42000920, A42000936, A42000937, A42000946, A43000978, A43000996, A43001011, A45001060, A45001064, A45001079, A46001141, A46001150, A46001178, A46001192, A46001195, A47001207, A47001211, A47001214, A47001220, A47001263, A48001277, A48001289, A48001307, A51001396, A57504300000018, A57504300000028, A57504300000044, A58504300000047, A58504300000053, A58504300000066, A58504300000074, A59504300000163, A5A504300000187, A21000011, A33000520, A25000149, A26000174, A3B000805, A46001135, A28000251, A21000010, A21000021, A24000086, A25000112, A26000155, A27000195, A28000245, A29000317, A2B000367, A2B000409, A2C000436, A33000521, A33000530, A33000535, A33000538, A34000555, A34000558, A34000573, A34000583, A34000598, A34000617, A35000647, A35000648, A35000660, A36000684, A36000703, A37000722, A37000731, A37000739, A38000762, A39000770, A39000775, A39000788, A3C000849, A42000880, A42000905, A42000908, A42000917, A42000929, A43000977, A43000994, A43000998, A43001010, A44001023, A45001075, A45001090, A45001102, A45001105, A46001126, A46001140, A46001159, A46001175, A46001185, A47001217, A48001308, A49001318, A49001337, A52001403, A52001405, A58504300000070, A21000036, A24000081, A24000085, A25000107, A25000125, A25000128, A25000134, A26000151, A26000152, A26000163, A27000199, A28000218, A28000237, A28000242, A28000285, A2A000333, A2B000356, A2B000359, A2B000373, A2B000382, A2B000386, A2B000387, A2B000388, A2B000390, A2B000392, A2B000401, A2B000406, A32000500, A33000526, A33000537, A33000542, A34000572, A34000576, A34000580, A34000584, A34000590, A34000594, A34000608, A34000610, A35000632, A35000662, A36000682, A36000689, A36000691, A36000693, A36000696, A36000697, A36000709, A36000713, A36000719, A37000726, A37000729, A37000733, A37000740, A38000745, A38000749, A38000750, A38000754, A38000757, A38000764, A39000777, A39000782, A39000784, A3B000792, A3C000810, A3C000830, A3C000832, A3C000838, A3C000839, A3C000840, A3C000842, A3C000843, A3C000844, A3C000847, A3C000851, A3C000852, A41000855, A41000856, A41000857, A41000860, A41000863, A41000864, A41000866, A41000867, A41000868, A41000870, A41000871, A41000874, A41000875, A41000876, A42000904, A42000910, A42000915, A42000918, A42000923, A42000926, A42000935, A42000938, A42000939, A42000940, A42000943, A42000948, A42000950, A42000953, A42000954, A42000955, A42000957, A42000958, A42000960, A42000961, A42000962, A42000963, A42000965, A42000966, A42000967, A42000968, A42000969, A43000970, A43000972, A43000975, A43000979, A43000981, A43000987, A43000990, A43000992, A43000993, A43001001, A43001004, A43001007, A43001012, A44001021, A44001025, A44001031, A44001037, A44001039, A44001042, A44001043, A44001046, A44001048, A45001063, A45001070, A45001071, A45001076, A45001080, A45001120, A45001122, A45001124, A46001128, A46001131, A46001136, A46001137, A46001138, A46001139, A46001145, A46001146, A46001149, A46001154, A46001155, A46001162, A46001165, A46001167, A46001171, A46001172, A46001176, A46001191, A47001202, A47001203, A47001204, A47001209, A47001226, A47001229, A47001233, A47001238, A47001252, A47001254, A47001256, A47001258, A47001267, A48001272, A48001276, A48001279, A48001287, A48001292, A48001293, A48001298, A48001302, A48001305, A49001310, A49001314, A49001315, A49001316, A49001317, A49001320, A49001321, A49001323, A49001324, A49001329, A49001334, A49001343, A4A001349, A4A001358, A4A001362, A51001371, A51001372, A51001375, A51001386, A51001387, A51001394, A51001397, A51001398, A57504300000010, A57504300000014, A57504300000014, A57504300000016, A57504300000019, A57504300000023, A57504300000024, A57504300000025, A57504300000026, A57504300000030, A57504300000033, A57504300000035, A57504300000036, A57504300000038, A57504300000039, A57504300000040, A57504300000043, A57504300000045, A58504300000059, A58504300000062, A58504300000085, A58504300000090, A58504300000097, A58504300000140, A59504300000151, A59504300000168, A5A504300000173, A5A504300000175, A5A504300000186, A5A504300000190, A5A504300000191, A24000080, A25000135, A46001186, A27000215, A27000196, A2B000402, A36000686, A36000688, A37000734, A39000765, A39000768, A3B000797, A41000859, A42000924, A45001099, A46001181, A48001296, A49001319, A4A001355, A57504300000031, A58504300000056, A58504300000078, DEMO00001, DEMO00006, A24000103, A34000561, A35000646, A36000671, A36000690, A37000741, A37000744, A38000751, A38000752, A39000787, A3C000821, A42000944, A23000050, A27000190, A28000248, A29000287, A2B000391, A34000600, A24000094, A28000219, A3C000814, A3C000827, A3C000836, A41000862, A42000882, A42000927, A43001008, A44001041, A45001067, A47001210, A51001393, A57504300000013, A57504300000015, A57504300000020, A57504300000021, A57504300000046, A58504300000051, A21000012, A21000027, A2A000342, A2B000360, A2B000362, A2B000366, A2B000368, A2B000369, A2B000370, A2B000371, A2B000375, A2B000376, A2B000377, A2B000379, A2B000380, A2B000384, A2B000389, A2B000394, A2B000396, A2B000400, A2B000403, A2B000404, A2B000405, A2B000410, A2B000412, A2B000416, A2B000419, A2B000423, A2B000425, A2B000426, A2B000427, A2B000429, A2B000430, A2B000431, A2B000432, A2C000442, A31000471, A32000512, A32000518, A33000532, A34000562, A34000613, A35000656, A35000657, A35000658, A36000685, A36000698, A36000704, A36000715, A37000737, A38000747, A39000779, A3B000801, A3C000822, A3C000823, A3C000831, A42000883, A42000884, A42000951, A43000997, A43001013, A45001056, A45001068, A45001074, A46001127, A47001222, A47001223, A47001234, A47001243, A48001281, A48001299, A48001306, A4A001345, A4B001365, A51001374, A51001381, A51001392, A51001399, A52001410, A52001416, A58504300000082, A58504300000087, A58504300000088, A58504300000092, A58504300000093, A58504300000099, A58504300000103, A58504300000104, A58504300000107, A59504300000157, A21000019, A25000113, A21000039, A26000168, A28000274, A2B000433, A49001338, A35000633, A35000634, A21000030, A24000093, A25000122, A25000127, A25000132, A26000175, A27000185, A28000256, A28000283, A29000288, A29000324, A2B000361, A2B000415, A36000672, A36000718, A38000759, A42000890, A45001072, A45001087, A45001098, A57504300000027, A57504300000032, A24000082, A3C000833, A25000117, A21000020, A28000225, A2B000418, A2B000428, A31000473, A32000510, A33000531, A34000619, A21000013, A21000032, A21000037, A25000124, A29000293, A29000316, A2A000329, A2C000464, A38000746, A39000773, A39000789, A3B000793, A45001033, A45001069
Products Sold
Serial numbers for domestic units: A21000015, A21000016, A21000018, A23000040, A23000042, A23000047, A24000051, A24000052, A24000054, A24000055, A24000056, A24000057, A24000060, A24000061, A24000067, A24000073, A24000076, A24000077, A24000084, A24000087, A24000096, A24000101, A24000104, A25000106, A25000108, A25000110, A25000115, A25000116, A25000118, A25000126, A25000130, A25000131, A25000133, A25000136, A25000137, A25000143, A25000144, A25000145, A25000146, A25000147, A25000148, A26000153, A26000154, A26000157, A26000159, A26000160, A26000161, A26000164, A26000165, A26000167, A26000170, A26000171, A26000173, A26000176, A26000178, A26000179, A26000180, A27000181, A27000184, A27000186, A27000188, A27000189, A27000192, A27000194, A27000197, A27000198, A27000200, A27000202, A27000203, A27000204, A27000210, A27000211, A27000212, A28000220, A28000226, A28000229, A28000230, A28000231, A28000235, A28000238, A28000241, A28000243, A28000247, A28000250, A28000253, A28000255, A28000257, A28000260, A28000262, A28000265, A28000267, A28000270, A28000273, A28000275, A28000276, A28000277, A28000280, A28000281, A29000289, A29000290, A29000292, A29000300, A29000310, A29000318, A29000319, A29000323, A29000325, A2A000327, A2A000330, A2A000335, A2A000337, A2A000338, A2A000340, A2A000344, A2A000345, A2A000348, A2A000349, A2A000350, A2A000353, A2A000354, A2B000358, A2B000365, A2B000372, A2B000374, A2B000381, A2B000385, A2B000395, A2B000399, A2B000408, A2B000411, A2B000420, 2C000437, A2C000438, A2C000439, A2C000440, A2C000441, 2C000443, A2C000444, A2C000445, A2C000446, A2C000447, 2C000448, A2C000449, A2C000450, A2C000451, A2C000452, 2C000455, A2C000456, A2C000457, A2C000458, A2C000459, 2C000460, A2C000462, A2C000463, A2C000465, A31000466, 31000467, A31000468, A31000470, A31000474, A31000475, A31000477, A31000478, A31000479, A31000480, A31000481, A31000482, A31000488, A31000489, A31000491, A31000492, A31000493, A32000483, A32000490, A32000495, A32000498, A32000499, A32000501, A32000502, A32000505, A32000507, A32000509, A32000513, A32000515, A32000516, A32000517, A33000523, A33000528, A33000534, A33000536, A33000540, A33000546, A33000549, A33000550, A34000556, A34000557, A34000559, A34000560, A34000563, A34000565, A34000567, A34000568, A34000577, A34000578, A34000582, A34000587, A34000588, A34000589, A34000595, A34000596, A34000597, A34000599, A34000603, A34000606, A34000607, A34000611, A34000612, A34000614, A34000615, A34000616, A34000621, A34000623, A34000627, A34000628, A34000629, A35000630, A35000636, A35000637, A35000641, A35000642, A35000643, A35000644, A35000645, A35000649, A35000650, A35000652, A35000654, A35000659, A35000663, A35000664, A35000665, A35000669, A36000670, A36000674, A36000677, A36000678, A36000687, A36000692, A36000694, A36000702, A36000705, A36000706, A36000707, A36000716, A36000717, A37000720, A37000721, A37000723, A37000732, A37000735, A37000736, A37000738, A37000743, A38000753, A38000756, A38000760, A39000767, A39000769, A39000776, A39000778, A39000780, A39000783, A3B000790, A3B000794, A3B000796, A3B000799, A3B000802, A3B000804, A3B000806, A3C000812, A3C000813, 3C000824, A3C000825, A3C000826, A3C000846, A3C000850, 3C000853, A3C000854, A41000858, A41000861, A41000865, A41000869, A41000872, A41000873, A42000885, A42000887, A42000889, A42000891, A42000892, A42000893, A42000894, A42000895, A42000896, A42000897, A42000898, A42000899, A42000901, A42000903, A42000906, A42000907, A42000912, A42000913, A42000916, A42000921, A42000922, A42000925, A42000928, A42000931, A42000932, A42000934, A42000941, A42000945, A42000947, A42000952, A42000959, A43000980, A43000982, A43000995, A43001003, A43001005, A43001006, A44001017, A44001018, A44001019, A44001022, A44001026, A44001027, A44001028, A44001032, A44001038, A44001045, A45001050, A45001051, A45001053, A45001058, A45001061, A45001066, A45001073, A45001077, A45001084, A45001089, A45001100, A45001104, A45001106, A45001112, A45001117, A46001125, A46001133, A46001142, A46001143, A46001144, A46001157, A46001160, A46001177, A46001184, A46001193, A46001198, A47001201, A47001208, A47001219, A47001225, A47001230, A47001235, A47001237, A47001245, A47001247, A47001250, A47001253, A47001259, A48001271, A48001282, A48001283, A48001284, A48001288, A48001290, A48001294, A48001295, A49001312, A49001313, A49001327, A49001341, A4A001347, A4A001353, A4A001357, A51001373, A51001383, 51001389. Serial Numbers for Foreign Units: A21000034 , A23000045 , A34000569 , A39000766 , A42000956 , A45001052 , A45001062 , A46001147 , A47001213 , A47001255 , A47001260 , A48001285 , A49001333 , A52001402 , A58504300000054 , A58504300000060 , A58504300000065 , A58504300000073 , A58504300000081 , A58504300000137 , A58504300000141 , A21000033 , A25000139 , A27000187 , A36000710 , A44001029 , A44001030 , A46001152 , A46001187 , A23000044 , A28000221 , A42000930 , A43001014 , A45001085 , A45001103 , A46001148 , A46001166 , A46001188 , A47001221 , A47001241 , A47001248 , A47001265 , A57504300000012 , A5A504300000177 , A5A504300000185 , A24000083 , A26000158 , A26000166 , A34000592 , A34000592 , A35000667 , A38000761 , A3C000818 , A3C000841 , A41000879 , A46001130 , A46001196 , A47001200 , A47001246 , A2A000346 , A21000017 , A21000028 , A24000089 , A24000098 , A27000207 , A28000269 , A28000271 , A28000284 , A32000497 , A33000524 , A33000527 , A34000574 , A34000581 , A36000695 , A36000700 , A37000742 , A3B000791 , A3B000795 , A3C000829 , A42000900 , A42000902 , A42000964 , A43001000 , A44001015 , A45001078 , A45001094 , A45001108 , A45001113 , A46001129 , A46001153 , A46001161 , A46001168 , A46001169 , A46001170 , A46001173 , A46001174 , A46001189 , A51001378 , A52001406 , A58504300000055 , A58504300000072 , A58504300000075 , A58504300000080 , A58504300000094 , A58504300000101 , A58504300000105 , A23000043 , A24000063 , A24000088 , A24000095 , A24000097 , A24000100 , A25000114 , A25000121 , A25000150 , A36000681 , A46001183 , A26000156 , A45001088 , A26000162 , A1C000003 , A28000252 , A2A000332 , A2A000334 , A31000486 , A32000506 , A25000142 , A28000216 , A28000222 , A34000591 , A42000949 , A21000024 , A23000046 , A24000070 , A24000102 , A26000169 , A26000172 , A28000217 , A28000278 , A29000298 , A29000308 , A31000469 , A34000579 , A34000586 , A34000605 , A34000624 , A39000785 , A44001034 , A45001092 , A46001164 , A47001212 , A47001257 , A48001300 , A49001322 , A49001331 , A51001385 , A51001395 , A21000022 , A21000023 , A23000041 , A23000048 , A24000071 , A24000074 , A24000079 , A24000091 , A24000092 , A25000120 , A25000129 , A25000138 , A27000183 , A27000191 , A27000201 , A27000205 , A27000209 , A28000223 , A28000228 , A28000233 , A28000236 , A28000249 , A28000254 , A28000258 , A28000272 , A28000282 , A28000307 , A29000286 , A29000295 , A29000296 , A29000299 , A29000302 , A29000303 , A29000305 , A29000307 , A29000320 , A29000321 , A2A000328 , A2A000336 , A2A000339 , A2A000352 , A2A000355 , A2B000413 , A2B000414 , A2B000417 , A2B000422 , A2B000424 , A2B000434 , A2B000435 , A2C000454 , A31000487 , A32000496 , A32000514 , A32000519 , A33000543 , A33000545 , A33000551 , A33000552 , A34000585 , A34000593 , A34000601 , A34000604 , A34000618 , A34000620 , A34000625 , A34000626 , A35000631 , A35000635 , A35000640 , A36000676 , A36000683 , A38000763 , A39000771 , A39000772 , A39000774 , A39000781 , A3B000809 , A3C000817 , A3C000819 , A3C000820 , A3C000828 , A3C000834 , A42000914 , A42000933 , A44001049 , A45001054 , A45001082 , A45001086 , A46001097 , A46001151 , A46001180 , A46001190 , A46001199 , A47001206 , A47001216 , A47001236 , A47001239 , A47001244 , A47001249 , A47001268 , A48001274 , A48001301 , A4A001356 , A4B001369 , A51001376 , A51001377 , A51001379 , A51001384 , A52001407 , A52001412 , A52001414 , A52001417 , A52001419 , A57504300000011 , A57504300000017 , A57504300000034 , A58504300000048 , A58504300000049 , A58504300000058 , A58504300000063 , A58504300000067 , A58504300000068 , A58504300000069 , A58504300000084 , A58504300000089 , A58504300000096 , A58504300000102 , A58504300000106 , A58504300000128 , A58504300000132 , A58504300000133 , A58504300000134 , A58504300000145 , A58504300000146 , A58504300000147 , A59504300000154 , A59504300000161 , A59504300000162 , A59504300000166 , A59504300000169 , A59504300000171 , A5A504300000172 , A5A504300000181 , A5A504300000197 , A5A504300000200 , A5A504300000210 , A5A504300000211 , A25000119 , A2B000398 , A34000570 , A35000668 , A36000675 , A3C000811 , A43000973 , A43000983 , A46001158 , A21000029 , A24000064 , A24000065 , A24000072 , A24000075 , A24000105 , A27000182 , A27000213 , A28000224 , A28000232 , A28000240 , A28000268 , A29000322 , A2A000326 , A2A000347 , A2B000357 , A2B000363 , A2B000393 , A2B000421 , A2C000461 , A31000485 , A32000503 , A33000533 , A33000539 , A33000541 , A33000544 , A33000548 , A33000553 , A34000564 , A34000571 , A35000638 , A35000653 , A36000673 , A36000699 , A36000701 , A37000725 , A37000728 , A37000730 , A38000755 , A38000758 , A39000786 , A3B000803 , A3C000835 , A3C000837 , A3C000845 , A41000878 , A42000881 , A42000886 , A43000985 , A43000999 , A44001016 , A44001036 , A44001044 , A45001055 , A45001059 , A45001081 , A45001083 , A45001095 , A45001107 , A45001109 , A45001111 , A45001114 , A45001115 , A45001116 , A45001118 , A45001123 , A46001134 , A46001156 , A46001194 , A46001197 , A47001215 , A47001227 , A47001231 , A47001232 , A47001242 , A47001251 , A47001261 , A47001262 , A47001264 , A47001266 , A48001270 , A48001286 , A48001291 , A48001303 , A49001325 , A49001326 , A49001328 , A4A001346 , A4A001348 , A4A001352 , A4A001354 , A4A001359 , A4A001360 , A4A001361 , A4A001363 , A4A001364 , A4B001366 , A51001370 , A52001400 , A52001401 , A52001404 , A52001408 , A52001409 , A52001411 , A52001415 , A52001418 , A57504300000009 , A57504300000037 , A58504300000050 , A58504300000052 , A58504300000071 , A58504300000077 , A58504300000079 , A58504300000086 , A58504300000091 , A58504300000095 , A58504300000100 , A58504300000129 , A58504300000130 , A58504300000131 , A58504300000135 , A58504300000136 , A58504300000138 , A58504300000139 , A58504300000142 , A58504300000144 , A59504300000150 , A59504300000155 , A59504300000156 , A59504300000158 , A59504300000159 , A59504300000170 , A5A504300000176 , A5A504300000178 , A5A504300000179 , A5A504300000182 , A5A504300000183 , A5A504300000188 , A5A504300000189 , A28000234 , A24000068 , A27000206 , A28000259 , A28000261 , A28000264 , A28000279 , A29000309 , A29000312 , A29000314 , A29000315 , A2B000397 , A2B000407 , A35000655 , A35000666 , A36000711 , A36000712 , A36000714 , A37000724 , A37000727 , A3C000816 , A42000888 , A43000971 , A43000974 , A43000984 , A43000986 , A43000989 , A43000991 , A43001002 , A44001040 , A45001057 , A45001065 , A46001182 , A47001205 , A47001224 , A48001297 , A48001304 , A49001332 , A57504300000029 , A59504300000160 , A5A504300000194 , A21000009 , A21000035 , A33000522 , A34000609 , A34000622 , A47001240 , A21000026 , A24000059 , A24000078 , A27000208 , A28000227 , A28000239 , A28000244 , A28000246 , A29000291 , A29000294 , A29000297 , A29000304 , A29000306 , A29000311 , A29000313 , A2A000351 , A2B000364 , A31000494 , A33000525 , A33000529 , A33000547 , A34000566 , A34000575 , A35000651 , A35000661 , A36000679 , A36000680 , A36000708 , A3B000800 , A3B000807 , A3B000808 , A3C000815 , A3C000848 , A41000877 , A42000909 , A42000911 , A42000919 , A42000920 , A42000936 , A42000937 , A42000946 , A43000978 , A43000996 , A43001011 , A45001060 , A45001064 , A45001079 , A46001141 , A46001150 , A46001178 , A46001192 , A46001195 , A47001207 , A47001211 , A47001214 , A47001220 , A47001263 , A48001277 , A48001289 , A48001307 , A51001396 , A57504300000018 , A57504300000028 , A57504300000044 , A58504300000047 , A58504300000053 , A58504300000066 , A58504300000074 , A59504300000163 , A5A504300000187 , A21000011 , A33000520 , A25000149 , A26000174 , A3B000805 , A46001135 , A28000251 , A21000010 , A21000021 , A24000086 , A25000112 , A26000155 , A27000195 , A28000245 , A29000317 , A2B000367 , A2B000409 , A2C000436 , A33000521 , A33000530 , A33000535 , A33000538 , A34000555 , A34000558 , A34000573 , A34000583 , A34000598 , A34000617 , A35000647 , A35000648 , A35000660 , A36000684 , A36000703 , A37000722 , A37000731 , A37000739 , A38000762 , A39000770 , A39000775 , A39000788 , A3C000849 , A42000880 , A42000905 , A42000908 , A42000917 , A42000929 , A43000977 , A43000994 , A43000998 , A43001010 , A44001023 , A45001075 , A45001090 , A45001102 , A45001105 , A46001126 , A46001140 , A46001159 , A46001175 , A46001185 , A47001217 , A48001308 , A49001318 , A49001337 , A52001403 , A52001405 , A58504300000070 , A21000036 , A24000081 , A24000085 , A25000107 , A25000125 , A25000128 , A25000134 , A26000151 , A26000152 , A26000163 , A27000199 , A28000218 , A28000237 , A28000242 , A28000285 , A2A000333 , A2B000356 , A2B000359 , A2B000373 , A2B000382 , A2B000386 , A2B000387 , A2B000388 , A2B000390 , A2B000392 , A2B000401 , A2B000406 , A32000500 , A33000526 , A33000537 , A33000542 , A34000572 , A34000576 , A34000580 , A34000584 , A34000590 , A34000594 , A34000608 , A34000610 , A35000632 , A35000662 , A36000682 , A36000689 , A36000691 , A36000693 , A36000696 , A36000697 , A36000709 , A36000713 , A36000719 , A37000726 , A37000729 , A37000733 , A37000740 , A38000745 , A38000749 , A38000750 , A38000754 , A38000757 , A38000764 , A39000777 , A39000782 , A39000784 , A3B000792 , A3C000810 , A3C000830 , A3C000832 , A3C000838 , A3C000839 , A3C000840 , A3C000842 , A3C000843 , A3C000844 , A3C000847 , A3C000851 , A3C000852 , A41000855 , A41000856 , A41000857 , A41000860 , A41000863 , A41000864 , A41000866 , A41000867 , A41000868 , A41000870 , A41000871 , A41000874 , A41000875 , A41000876 , A42000904 , A42000910 , A42000915 , A42000918 , A42000923 , A42000926 , A42000935 , A42000938 , A42000939 , A42000940 , A42000943 , A42000948 , A42000950 , A42000953 , A42000954 , A42000955 , A42000957 , A42000958 , A42000960 , A42000961 , A42000962 , A42000963 , A42000965 , A42000966 , A42000967 , A42000968 , A42000969 , A43000970 , A43000972 , A43000975 , A43000979 , A43000981 , A43000987 , A43000990 , A43000992 , A43000993 , A43001001 , A43001004 , A43001007 , A43001012 , A44001021 , A44001025 , A44001031 , A44001037 , A44001039 , A44001042 , A44001043 , A44001046 , A44001048 , A45001063 , A45001070 , A45001071 , A45001076 , A45001080 , A45001120 , A45001122 , A45001124 , A46001128 , A46001131 , A46001136 , A46001137 , A46001138 , A46001139 , A46001145 , A46001146 , A46001149 , A46001154 , A46001155 , A46001162 , A46001165 , A46001167 , A46001171 , A46001172 , A46001176 , A46001191 , A47001202 , A47001203 , A47001204 , A47001209 , A47001226 , A47001229 , A47001233 , A47001238 , A47001252 , A47001254 , A47001256 , A47001258 , A47001267 , A48001272 , A48001276 , A48001279 , A48001287 , A48001292 , A48001293 , A48001298 , A48001302 , A48001305 , A49001310 , A49001314 , A49001315 , A49001316 , A49001317 , A49001320 , A49001321 , A49001323 , A49001324 , A49001329 , A49001334 , A49001343 , A4A001349 , A4A001358 , A4A001362 , A51001371 , A51001372 , A51001375 , A51001386 , A51001387 , A51001394 , A51001397 , A51001398 , A57504300000010 , A57504300000014 , A57504300000014 , A57504300000016 , A57504300000019 , A57504300000023 , A57504300000024 , A57504300000025 , A57504300000026 , A57504300000030 , A57504300000033 , A57504300000035 , A57504300000036 , A57504300000038 , A57504300000039 , A57504300000040 , A57504300000043 , A57504300000045 , A58504300000059 , A58504300000062 , A58504300000085 , A58504300000090 , A58504300000097 , A58504300000140 , A59504300000151 , A59504300000168 , A5A504300000173 , A5A504300000175 , A5A504300000186 , A5A504300000190 , A5A504300000191 , A24000080 , A25000135 , A46001186 , A27000215 , A27000196 , A2B000402 , A36000686 , A36000688 , A37000734 , A39000765 , A39000768 , A3B000797 , A41000859 , A42000924 , A45001099 , A46001181 , A48001296 , A49001319 , A4A001355 , A57504300000031 , A58504300000056 , A58504300000078 , DEMO00001 , DEMO00006 , A24000103 , A34000561 , A35000646 , A36000671 , A36000690 , A37000741 , A37000744 , A38000751 , A38000752 , A39000787 , A3C000821 , A42000944 , A23000050 , A27000190 , A28000248 , A29000287 , A2B000391 , A34000600 , A24000094 , A28000219 , A3C000814 , A3C000827 , A3C000836 , A41000862 , A42000882 , A42000927 , A43001008 , 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Philips Ultrasound, Inc. is recalling Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (850 due to The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
Recommended Action
Per FDA guidance
On May 6, 2005 the firm mailed a letter, via return receipt requested, to customers. The letter advised of the problem, and provided instructions to create new low power presets. The letter also advised that software would be issued on/before November 2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026