Reported Mar 12, 2014 · Terminated
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System;…
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System |
| 2 | TXS-101/R Aquilion RXL Computed Tomography X-Ray System |
| 3 | TSX-301A Aquilion One Computed Tomography X-Ray System |
| 4 | TSX-301B Aquilion Premium Computed Tomography X-Ray System |
| 5 | 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. |
- Lot codes and dates
341 of 341 codes
SERIAL NUMBER JDA1062176JDA1062177JDA1072183JDA1072184JDA1072186JDA1072187JDA1082188JDA1082189JDA1082190JDA10X2191JDA10X2192JDA10X2193JDA10X2194JDA10X2195JDA10X2196JDA10X2197JDA10X2198JDA10Y2199JDA10Y2200JDA10Y2201JDA10Y2202JDA10Y2203JDA10Y2204JDA10Y2205JDA10Z2206JDA10Z2207JDA10Z2209JDA10Z2210JDA10Z2211JDA10Z2212JDA10Z2213JDA10Z2214JDA10Z2215JDA1112216JDA1112217JDA1112218JDA1112219JDA1112221JDA1112222JDA1112224JDA1112225JDA1112226JDA1112227JDA1122231JDA1122234JDA1142236JDA1162237JDA1162238JDA1162239JDA1182240JDA1182241JDA1182242JDA1182243JDA1182244JDA11X2245JDA11X2246JDA11X2247JDA11Z2249JDA11Z2250JDA11Z2252
- Amount recalled
- 338 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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