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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66527

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 01, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Toshiba American Medical Systems Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Z-1113-2014
Recall number
Z-1113-2014
Initiated
October 01, 2013
Classification
Class II
Status
Terminated
Quantity
338 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
problem of the X-ray output control software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.

Code information

SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238, JDA1162239, JDA1182240, JDA1182241, JDA1182242, JDA1182243, JDA1182244, JDA11X2245, JDA11X2246, JDA11X2247, JDA11Z2249, JDA11Z2250, JDA11Z2252, JDA11Z2253, JDA11Z2254, JDA11Z2255, JDA1222257, JDA1222258, JDA1222259, JDA1222260, JDA1222261, JDA1242264, JDA1252265, JDA1252266, JDA1252267, JDA12Z2271, JDA1312272, JGA1062178, JGA1062181, JGA1062182, JGA1112220, JGA1112228, JGA11Z2256, JGA1222262, JGA12X2269, JLA1062179, JLA1062180, JLA1072185, JLA10Z2208, JLA1122232, JLA1122233, JLA1132235, JLA11Y2248, JLA11Z2251, JLA1232263, JLA1262268, JLA12Y2270, KDA1062080, KDA1072081, KDA1072082, KDA1072083, KDA1072085, KDA1072086, KDA1072088, KDA1082090, KDA1082091, KDA1082092, KDA1092093, KDA10X2094, KDA10X2095, KDA10X2096, KDA10X2097, KDA10X2098, KDA10X2099, KDA10Y2100, KDA10Y2101, KDA10Y2102, KDA10Z2104, KDA1112107, KDA1122110, KDA1122111, KDA1132113, KDA1142114, KDA1152115, KDA1152116, KDA1152117, KDA1152118, KDA1162119, KDA1162120, KDA1162121, KDA1162122, KDA1162123, KDA1162124, KDA1172125, KDA1182126, KDA1182127, KDA1182128, KDA1182129, KDA1192130, KDA1192131, KDA11X2132, KDA11X2133, KDA11Y2134, KDA11Z2136, KDA11Z2137, KDA11Z2138, KDA11Z2139, KDA11Z2140, KDA1222141, KDA1222142, KDA1222143, KDA1232144, KDA1242145, KDA1242146, KDA1252147, KDA1272148, KDA1282149, KDA1292151, KDA12X2152, KDA12Y2153, KDA12Z2154, KDA1322155, KGA1082089, KGA10Z2103, KGA10Z2105, KGA1112106, KGA1112108, KGA1122109, KGA1122112, KGA11Z2135, KLA1072084, KLA1072087, KLA1292150, RDA1292019, RDA12X2023, RDA12X2024, RDB12Y2029, RDB12Z2032, RDB1312037, RDB1312038, RGA12X2025, RGB12Y2028, RGB1312034, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, 2DA0962116, 2DA0972123, 2DA0982131, 2DA0982133, 2DA09X2139, 2DA09X2143, 2DA09Y2148, 2DA09Y2151, 2DA09Z2158, 2DA09Z2161, 2DA09Z2162, 2DA1012165, 2DA1012167, 2DA1012168, 2DA1012169, 2DA1012170, 2DA1012174, 2DA1062208, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222, 2DB10X2241, 2DB10Y2253, 2DB10Y2257, 2DB10Z2265, 2DB1112275, 2DB1112283, 2DB1122284, 2DB1122291, 2DB1122294, 2DC1142308, 2DC1142311, 2DC1152316, 2DC1162324, 2DC1172328, 2DC1172332, 2DC1172333, 2DC11X2352, 2DC11Y2365, 2DC11Y2367, 2DC11Z2372, 2DC11Z2374, 2DC1212377, 2DC1212383, 2DC1232392, 2DC1232393, 2DC1232396, 2DC1232397, 2DC1232398, 2DC1242407, 2DC1242409, 2DC1252410, 2DC1262412, 2DC1272417, 2DC1272421, 2DC1282423, 2DC12X2427, 2DC12Y2430, 2DC12Y2431, 2DC12Z2433, 2DC1312435, 2DC1312436, 2DC1322437, 1DA0962006, 1DA0972007, 1DA0972008, 1DA0992011, 1DA09Y2014, 1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019, 1DB10Y2020, 1DB10Y2021, 1DB10Y2022, 1DB1112025, 1DB1122027, 1DC1142030, 1DC1152031, 1DC1162032, 1DC1162033, 1DC1172035, 1DC11Y2037, 1DC11Y2038, 1DC11Z2040, 1DC1222042, 1DC1232043, 1DC1232044, 1DC1252045, 1DC1252046, 1DC1262048, 1DC1272050, 1DC1282051, 1DC1292052, 1DC12X2053, 1DC12Y2054, 1DC12Y2055, 1DC12Z2056, 1DC1312057, 1DC1312058, 1DC1342059, 1GC1262047, 1GC1272049, 1DA1222096, 1DA1222097, 1DA1232099, 1DA1232100, 1DA1232103, 1DA1252124, 1DA1252131, 2DA1252001, 2DA1262003, 2DA1272004, 2DA1272005, 2DA1272006, 2DA1282007, 2DA1292008, 2DA12X2009, 2DA12X2010, 2DA12X2012, 2DA12X2013, 2DA12Y2014, 2DA12Y2015, 2DA12Y2016, 2DA12Z2017, 2DA12Z2018, 2DA1312019, 2DA1312020, 2DA1312021, 2DA1312022, 2GA1262002, 2GA12X2011, 2DA1072211, 2DA08X2063, 2DC11Y2368.

Distribution pattern

Nationwide Distribution.