Philips Medical Systems: 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.

Recall number

Z-0523-2009

Recalling firm

Philips Medical Systems

Product

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.

Status

Terminated

Initiated

2008-08-12

Posted

2008-12-31

Terminated

2011-07-14

Reason

The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.

Root cause

Software design

Action

On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. "In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system."

Quantity

1902 Units

Distribution

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).

Lot, serial or model codes

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, 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.

510(k) numbers

["K031552"]

PMA numbers

not on file

Product code

IYN

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy