FDA Device recall Z-1113-2014
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System by Toshiba American Medical Systems, citing 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 correctl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1113-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-01 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1113-2014%22
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