Toshiba American Medical Systems Inc: Aquilion 64 CT System; Model number TSX-101 A/H The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

Recall number

Z-1167-2010

Recalling firm

Toshiba American Medical Systems Inc

Product

Aquilion 64 CT System; Model number TSX-101 A/H The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

Status

Terminated

Initiated

2009-01-08

Posted

2010-03-19

Terminated

2012-06-01

Reason

Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.

Root cause

Component design/selection

Action

Customer notification was sent and a software upgrade will be issued to all customers affected by the field correction. If you have questions, please call (800) 521-1968.

Quantity

397

Distribution

Nationwide

Lot, serial or model codes

Serial Numbers: A4602001, A4612005, A4612006, A4612008, A4612011, A4622019, A4622021, A4622023, A4622027, A4622029, A4622032, A4622035, A4622040, A5512046, A5512047, A5512049, A5512050, A5512051, A5512053, A5512054, A5512056, A5512059, A5512060, A5512061, A5512062, A5512064, A5512065, A5512067, A5512069, A5512071, A5512072, A5522073, A5522075, A5522076, A5522077, A5522079, A5522081, A5522083, A5522084, A5522085, A5522086, A5522087, A5522088, A5522090, A5522091, A5522093, A5522095, A5522097, A5532107, A5532109, DDA0542114, DDA0542116, DDA0542118, DDA0542119, DDA0552121, DDA0552122, DDA0552123, DDA0552124, DDA0552126, DDA0552127, DDA0572131, DDA0572132, DDA0572134, DDA0582136, DDA0582137, DDA0582139, DDA0591245, DDA0592147, DD0592152, A5522089, A5532100, A5532104, DGA0592146, DLA05Y2159, DLA05Y2159, DLA05Y2163, DLA05Z2164, DLA05Z2165, DLA05Z2168, DLA05Z2169, DLA05Z2170, EDA0552039, EDA0562046, EDA0562048, EDA0562052, EDA0562058, EDA0562059, EDA0562061, EDA0562065, EDA0562068, EDA0562070, EDA0572077, EDA0572080, EDA0572082, EDA0572086, EDA0572091, EDA0572095, EDA0572100, EDA0572102, EDA0582105, EDA0582109, EDA0582110, EDA0582111, EDA0582119, EDA0582124, EDA0582126, EDA0582128, EDA0592133, EDA0592134, EDA0592137, EDA0592139, EDA0592140, EDA0592142, EDA0592147, EDA0592148, EDA0592149, ELA05X2154, ELA05X2155, ELA05X2156, ELA05X2159, ELA05X2160, ELA05X2176, ELA05X2179, ELA05X2182, ELA05X2188, ELA05X2189, ELA05X2191, ELA05Y2194, ELA05Y2195, ELA05Y2196, ELA05Y2200, ELA05Y2205, ELA05Y2209, ELA05Y2210, ELA05Y2211, ELA05Y2221, ELA05Y2224, ELA05Y2226, ELA05Z2235, ELA05Z2236, ELA05Z2237, ELA05Z2241, ELA05Z2244, ELA05Z2246, ELA05Z2248, ELA05Z2251, ELA05Z2253, EGA05Y2228, HDA0612011, HDA0612012, HDA0612014, HDA0612015, HDA0612027, HDA0612028, HDA0612029, HDA0612030, HDA0612042, HDA0612043, HDA0612047, HDA0612049, HDA0612050, HDA0622054, HDA0622056, HDA0622057, HDA0622058, HDA0622061, HDA0622063, HDA0622065, HDA0622069, HDA0622070, HDA0622071, HDA0622074, HDA0622075, HDA0622076, HDA0622077, HDA0622079, HDA0622080, HDA0622082, HDA0622085, HDA0622086, HDA0622089, HDA0632092, HDA0632093, HDA0632094, HDA0632095, HDA0632097, HDA0632098, HDA0632100, HDA0632102, HDA0632103, HDA0632106, HDA0632110, HDA0632113, HDA0632117, HDA0632119, HDA0632120, HDA0632122, HDA0632123, HDA0632126, HDA0632128, HDA0632130, HDA0632131, HDA0632133, HDA0642138, HDA0642139, HDA0642151, HDA0642157, HDA0642158, HDA0652186, HDA0652194, HDA0652201, HDA0652202, HDA0662209, HDA0662211, HDA0662212, HDA0662218, HDA0662226, HDA0662227, HDA0662230, HDA0662231, HDA0662234, HDA0662237, HDA0662238, HDA0672241, HDA0672243, HDA0672244, HDA0672247, HDA0672250, HDA0672251, HDA0672256, HDA0672261, HDA0672263, HDA0672264, HDA0682268, HDA0682269, HDA0682273, HDA0682276, HDA0682277, HDA0682279, HDA0682280, HDA0682281, HDA0682283, HDA0682284, HDA0682285, HDA0682286, HDA0682287, HDA0682289, HDA0682290, HDA0682291, HDA0682293, HDA0682295, HDA0682296, HDA0682297, HDA0682298, HDA0682299, HDA0682300, HDA0682302, HDA0682303, HDA0682306, HDA0682307, HDA0682308, HDA0682309, HDA0682310, HDA0682311, HDA0682312, HDA0692314, HDA0692315, HDA0692329, HDA0692331, HDA0692332, HDA0692334, HDA0692337, HDA06X2345, HDA06X2346, HDA06X2349, HDA06X2351, HDA06X2353, HDA06X2354, HDA06X2357, HDA06X2360, HDA06X2361, HDA06X2363, HDA06X2364, HDA06X2367, HDA06X2368, HDA06X2371, HDA06X2373, HDA06X2379, HDA06Y2381, HDA06Y2382, HDA06Y2387, HDA06Y2390, HDA06Y2392, HDA06Y2394, HDA06Y2395, HDA06Y2396, HDA06Y2397, HDA06Y2402, HDA06Y2404, HDA06Y2406, HDA06Y2408, HDA06Y2409, HDA06Y2411, HDA06Y2412, HDA06Y2417, HDA06Y2419, HDA06Y2420, HDA06Y2422, HDA06Y2424, HDA06Y2427, HDA06Z2431, HDA06Z2436, HDA06Z2437, HDA06Z2439, HDA06Z2440, HDA06Z2441, HDA06Z2442, HDA06Z2448, HDA06Z2453, HDA06Z2464, HDA06Z2470, HDA06Z2477, HDA06Z2479, HDA0712484, HDA0712486, HDA0712487, HDA0712491, HDA0712493, HDA0712505, HDA0712508, HDA0712509, HDA0712511, HDA0712512, HDA0712522, HDA0712525, HDA0712530, HDA0712536, HDA0722541, HDA0722543, HDA0722544, HDA0722552, HDA0722553, HDA0722555, HDA0722556, HDA0722559, HDA0722560, HDA0722562, HDA0722563, HDA0722567, HDA0722568, HDA0722572, HDA0722574, HDA0722575, HDA0722577, HDA0722578, HDA0722580, HDA0722581, HDA0722582, HDA0722583, HDA0722586, HDA0722588, HDA0722595, HDA0722597, HDA0722598, HDA0722599, HDA0722602, HDA0722606, HDA0732609, HDA0732610, HDA0732614, HDA0732615, HDA0732619, HDA0732620, HDA0732623, HDA0732624, HDA0732629, HDA0732633, HDA0732634, HDA0732635, HDA0732637, HDA0732638, HDA0732639, HDA0732660, HDA0732664, HDA0752698, HDA0752708, HDA0752712, HDA0752716, HDA0752721, HDA0762727, HDA0762729, HDA0762731, HDA0762734, HDA0762737, HDA0762739, HDA0762740, HDA0762744, HDA0762747, HDA0762749, HDA0762750, HDA0762751, HDA0762753, HDA0762754, HDA0762756, HDA0762757, HDA0762758, HDA0762760, HDA0762761, HDA0762763, HDA0762764, HDA0762765, HDA0772768, HDA0772769, HDA0772772, HDA0772775, HDA0772776, HDA0772778, HDA0772780, HDA0772781, HDA0772784, HDA0772785, HDA0772788, HDA0772790, HDA0772792, HDA0772794, HDA0772795, HDA0772796, HDA0772799, HDA0772800, HDA0772804, HDA0772805, HDA0772806, HDA0772807, HDA0772808, HDA0772810, HDA0772811, HDA0772814, HDA0772815, HDA0772823, HDA0772824, HDA0782827, HDA0782831, HDA0782846, HDA0782848, HDA0782851, HDA0782854, HDA0782859, HDA0782861, HDA0782862, HDA0782863, HDA0782866, HDA0782868, HDA0782869, HDA0782876, HDA0782878, HDA0782879, HDA0782882, HDA0782883, HDA0782887, HDA0792895, HDA0792897, HDA0792898, HDA0792900, HDA07X2910, HDA07X2911, HDA07X2916, HDA07X2918, HDA07X2921, HDA07X2923, HDA07X2924, HDA07X2930, HDA07X2931, HDA07X2937, HDA07X2939, HDA07X2940, HDA07X2945, HDA07X2947, HDA07Y2964, HDA07Y2978, HDA07Y2980, HDA07Y2983, HDA07Y2986, HDA07Y2988, HDA07Y2991, HDA07Y2992, HDA07Y2994, HDA07Y2995, HDA07Y2997, HDA07Y3001, HDA07Y3002, HDA07Y3003, HDA07Y3006, HDA07Z3009, HDA07Z3010, HDA07Z3011, HDA07Z3014, HDA07Z3015, HDA07Z3028, HDA07Z3031, HDA07Z3035, HDA07Z3039, HDA07Z3042, HDA07Z3046, HDA07Z3048, HDA07Z3049, HDA07Z3050, HDA0813061, HDA0813062, HDA0813063, HDA0813071, HDA0813072, HDA0813073, HDA0813076, HDA0813077, HDA0813078, HDA0813081, HDA0813082, HDA0813085, HDA0813089, HDA0813090, HDA0813093, HDA0813095, HDA0813102, HDA0823109, HDA0823113, HDA0823117, HDA0823120, HDA0823122, HDA0823123, HDA0823127, HDA0823135, HDA0823137, HDA0823140, HDA0823144, HDA0823147, HDA0823150, HDA0823153, HDA0843200, HGA0652177, HGA0672252, HGA0672255, HGA0672258, HGA06X2365, HGA0712537, HGA0722591, HGA0732650, HGA0762741, HGA0762742, HGA0772816, HGA0772819, HGA0772820, HGA0843204, HGA0843206, IDA0612001, IDA0612003, IDA0612004, IDA0612005, IDA0612006, IDA0612007, IDA0612008, IDA0622013, IDA0622014, IDA0622016, IDA0632018, IDA0632019, IDA0632020, IDA0632021, IDA0632022, IDA0632023, IDA0632024, IDA0662031, IDA0662032, IDA0672034, IDA0672035, IDA0692041, IDA0692043, IDA0692044, IDA0692045, IDA0692046, IDA0692047, IDA06X2048, IDA06Y2053, IDA06Y2054, IDA06Y2055, IDA06Y2056, IDA06Z2057, IDA06Z2059, IDA0712061, IDA0712063, IDA0712064, IDA0712066, IDA0712067, IDA0712068, IDA0722070, IDA0722071, IDA0722072, IDA0722073, IDA0722074, IDA0752080, IDA0752081, IDA0752082, IDA0752083, IDA0762089, IDA0762090, IDA0762093, IDA0762094, IDA0762095, IDA0762096, IDA0772097, IDA0772099, IDA0782103, IDA0792107, IDA0792108, IDA0792109, IDA07X2112, IDA07X2113, IDA07Y2118, IDA07Y2120, IDA07Y2124, IDA07Z2128, IDA0812133, IDA0812134, IDA0812136, IDA0812137, IDA0822139, IDA0822141, IDA0822143, IDA0822144, IDA0822145, IDA0832146, IDA0832147, IDA0832148, IDA0832149, IDA0832150, IDA0842151, IDA0852156, IDA0852157, IDA0862158, IDA0862160, IDA0862161, IDA0862162, IGA0672036, IGA0742078, IGA0752084, IGA0752086, IGA0762091, IGA0842152, JDA0872035, JDA0872036, JDA0872037, JDA0882039, JDA0882040, JDA0882041, JDA0882042, JDA0882043, JDA0882044, JDA0882045, JDA0882046, JDA0882047, JDA0882048, JDA0892049, JDA0892050, JDA0892051, JDA0892052, JGA0872029, JGA0872034, JGA0882038, KDA0872005, KDA0872006, KDA0882007, KDA0882008, KDA0882009, KDA0882010, KDA0892011, KGA0852001, and KGA0872004

510(k) numbers

["K080211"]

PMA numbers

not on file

Product code

JAK

Firm FEI

2020563

Firm city

Tustin

Firm state

CA

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

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