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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion 64 CT System

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  Class 2 Device Recall Aquilion 64 CT System see related information
Date Initiated by Firm January 08, 2009
Date Posted March 19, 2010
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-1167-2010
Recall Event ID 52825
510(K)Number K080211  
Product Classification System, x-ray, tomography, computed - Product Code JAK
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
Code Information 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      
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 397
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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