Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System Recalled by Toshiba American Medical Systems Inc Due to Toshiba intitiated this recall because their investigation revealed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Toshiba American Medical Systems Inc directly.
Affected Products
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.
Quantity: 338 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Toshiba American Medical Systems Inc
Toshiba American Medical Systems Inc has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report