Events

Recall of Device Recall Aquilion 32 CT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52825
  • Event Risk Class
    Class 2
  • Event Number
    Z-1164-2010
  • Event Initiated Date
    2009-01-08
  • Event Date Posted
    2010-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84082
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • 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.
  • 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.

Device

Device Recall Aquilion 32 CT System
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Aquilion 32 CT System; Model number TSX-101 A/K || 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
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA