Philips Medical Systems

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 HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. || Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.

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, 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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, 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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, 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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, 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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, A58504300000137, A58504300000138, A58504300000139, A58504300000140, A58504300000141, A58504300000142, A58504300000143, A58504300000144, A58504300000145, A58504300000146, A58504300000147, A59504300000148, A59504300000149, A59504300000150, A59504300000151, A59504300000152, A59504300000153, A59504300000154, A59504300000155, A59504300000156, A59504300000157, A59504300000158, A59504300000159, A59504300000160, A59504300000161, A59504300000162, A59504300000163, A59504300000164, A59504300000165, A59504300000166, A59504300000167, A59504300000168, A59504300000169, A59504300000170, A59504300000171, A5A504300000172, A5A504300000173, A5A504300000174, A5A504300000175, A5A504300000176, A5A504300000177, A5A504300000178, A5A504300000179, A5A504300000180, A5A504300000181, A5A504300000182, A5A504300000183, A5A504300000184, A5A504300000185, A5A504300000186, A5A504300000187, A5A504300000188, A5A504300000189, A5A504300000190, A5A504300000191, A5A504300000192, A5A504300000193, A5A504300000194, A5A504300000195, A5A504300000196, A5A504300000197, A5A504300000198, A5A504300000199, A5A504300000200, A5A504300000201, A5A504300000202, A5A504300000203, A5A504300000204, A5A504300000205, A5A504300000206, A5A504300000207, A5A504300000208, A5A504300000209, A5A504300000210, A5A504300000211, A5A504300000212, A5A504300000213, A5A504300000214, A5B504300000212, A5B504300000213, A5B504300000214, A5B504300000215, A5B504300000216, A5B504300000217, A5B504300000218, A5B504300000219, A5B504300000220, A5B504300000221, A5B504300000222, A5B504300000223, A5B504300000224, A5B504300000225, A5B504300000226, A5B504300000227, A5B504300000228, A5B504300000229, A5B504300000230, A5B504300000231, A5B504300000232, A5B504300000233, A5B504300000234, A5B504300000235, A5B504300000236, A5B504300000237, A5B504300000238, A5B504300000239, A5B504300000240, A5B504300000241, A5B504300000242, A5B504300000243, A5B504300000244, A5B504300000245, A5B504300000246, A5B504300000247, A5B504300000248, A5B504300000249, A5B504300000250, A5B504300000251, A5B504300000252, A5B504300000253, A5B504300000254, A5B504300000255, A5B504300000256, A5B504300000257, A5B504300000258, A5B504300000259, A5B504300000260, A5B504300000261, A5B504300000262, A5B504300000263, A5B504300000264, A5B504300000265, A5B504300000266, A5B504300000267, A5B504300000268, A5B504300000269, A5B504300000270, A5B504300000271, A5B504300000272, A5B504300000273, A5B504300000274, A5B504300000275, A5B504300000276, A5B504300000277, A5B504300000278, A5B504300000279, A5B504300000280, A5B504300000281, A5B504300000282, A5B504300000283, A5B504300000284, A5B504300000285, A5B504300000286, A5B504300000287, A5B504300000288, A5B504300000289, A5B504300000290, A5B504300000291, A5B504300000292, A5B504300000293, A5B504300000294, A5B504300000295, A5B504300000296, A5B504300000297, A5B504300000298, A5B504300000299, A5B504300000300, A5B504300000301, A5B504300000302, A5B504300000303, A5B504300000304, A5B504300000305, A5B504300000306, A5B504300000307, A5B504300000308, A5B504300000309, A5B504300000310, A5B504300000311, A5B504300000312, A5B504300000313, A5B504300000314, A5B504300000315, A5B504300000316, A5C504300000317, A5C504300000318, A5C504300000319, A5C504300000320, A5C504300000321, A5C504300000322, A5C504300000323, A5C504300000324, A5C504300000325, A5C504300000326, A5C504300000327, A5C504300000328, A5C504300000329, A5C504300000330, A5C504300000331, A5C504300000332, A5C504300000333, A5C504300000334, A5C504300000335, A5C504300000336, A5C504300000337, A5C504300000338, A5C504300000339, A5C504300000340, A5C504300000341, A5C504300000342, A5C504300000343, A5C504300000344, A5C504300000345, A5C504300000346, A5C504300000347, A5C504300000348, A5C504300000349, A5C504300000350, A5C504300000351, A5C504300000352, A5C504300000353, A5C504300000354, A5C504300000355, A5C504300000356, A5C504300000357, A5C504300000358, A5C504300000359, A5C504300000360, A5C504300000362, A5C504300000363, A5C504300000364, A5C504300000365, A5C504300000366, A5C504300000367, A5C504300000368, A61504300000369, A61504300000370, A61504300000371, A61504300000372, A61504300000373, A61504300000374, A61504300000375, A61504300000376, A61504300000377, A61504300000378, A61504300000379, A61504300000380, A61504300000381, A61504300000382, A61504300000383, A61504300000384, A62504300000386, A62504300000387, A62504300000388, A62504300000389, A62504300000390, A62504300000391, A62504300000392, A62504300000393, A62504300000394, A62504300000395, A62504300000396, A62504300000397, A62504300000398, A62504300000399, A62504300000400, A62504300000401, A62504300000402, A62504300000403, A62504300000404, A62504300000405, A62504300000406, A64504300000407, A64504300000408, A64504300000409, A64504300000410, A64504300000411, A64504300000412, A64504300000413, A64504300000414, A64504300000415, A64504300000416, A64504300000417, A64504300000418, A65504300000419, A65504300000420, A65504300000421, A65504300000422, A65504300000423, A65504300000424, A65504300000425, A65504300000426, A65504300000427, A65504300000428, A65504300000429, A65504300000430, A65504300000431, A65504300000432, A65504300000433, A65504300000434, A65504300000435, A65504300000436, A65504300000437, A65504300000438, A65504300000439, A65504300000440, A65504300000441, A65504300000442, A65504300000443, A65504300000444, A65504300000445, A65504300000446, A65504300000447, A65504300000448, A65504300000449, A65504300000450, A65504300000451, A65504300000452, A65504300000453, A65504300000454, A65504300000455, A65504300000456, A65504300000457, A65504300000458, A65504300000459, A65504300000460, A65504300000461, A65504300000462, A67504300000463, A67504300000464, A67504300000465, A67504300000466, A67504300000467, A67504300000468, A67504300000469, A67504300000470, A67504300000471, A67504300000472, A67504300000473, A67504300000474, A67504300000475, A67504300000476, A67504300000477, A67504300000478, A67504300000479, A67504300000480, A67504300000481, A67504300000482, A67504300000483, A67504300000484, A67504300000485, A67504300000486, A67504300000487, A68504300000488, A68504300000489, A68504300000490, A68504300000491, A68504300000492, A68504300000493, A68504300000494, A68504300000495, A68504300000496, A68504300000497, A68504300000498, A68504300000499, A68504300000500, A68504300000501, A68504300000502, A68504300000503, A68504300000504, A68504300000505, A69504300000506, A69504300000507, A69504300000508, A69504300000509, A69504300000510, A69504300000511, A69504300000512, A69504300000513, A69504300000514, A69504300000515, A69504300000516, A69504300000517, A69504300000518, A69504300000519, A6A504300000520, A6A504300000521, A6A504300000522, A6A504300000523, A6A504300000524, A6A504300000525, A6A504300000526, A6A504300000527, A6A504300000528, A6A504300000529, A6A504300000530, A6A504300000531, A6A504300000532, A6A504300000533, A6A504300000534, A6A504300000535, A6A504300000536, A6A504300000537, A6A504300000538, A6A504300000539, A6A504300000540, A6A504300000541, A6A504300000542, A6A504300000543, A6A504300000544, A6A504300000545, A6C504300000546, A6C504300000547, A6C504300000548, A6C504300000549, A6C504300000550, AA49001311, DEMO00001, DEMO00005, and DEMO00006.

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.

Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.

Cardiovascular Devices

2

No

Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK

Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station || Models: M3145, M3150, M3154, M3155, M3169

Serial Numbers: 4711A00132 4725A02724 4711A00354 4725A02791 4716A00562 4725A02897 4717A00702 4725A02927 4717A00703 4725A03255 4717A00705 4732A03719 4717A00706 4732A03725 4717A00724 4732A03764 4717A00725 4732A03765 4717A00799 4732A03766 4717A00857 4732A04028 4718A00957 4732A04031 4718A01077 4732A04134 4718A01078 4732A04178 4718A01120 4732A04400 4718A01121 4732A04623 4718A01454 4732A04671 4721A01670 4732A04675 4721A01711 4732A04746 4721A01731 4732A04868 4721A01773 4732A04869 4721A01797 4732A04870 4721A01828 4732A04871 4721A01919 4732A04872 4721A01993 4732A04873 4721A01994 4732A04874 4721A01997 4732A04875 4721A02164 4732A04876 4725A02354 4732A04877 4732A04890 4732A04896

Cardiovascular Devices

2

No

Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.

Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810

Softwarre versions: C.00.00 through C.00.06

Cardiovascular Devices

2

No

Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE

CareVue Chart Release C ,Versions C.00.00 through C.00.06 || Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.