Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aquilion Lightning CT System iStation cover Recalled by Toshiba American Medical Systems Inc Due to Toshiba American Medical Systems, Inc. is recalling the...
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
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning 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: 1 unit
Why Was This Recalled?
Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Where Was This Sold?
US in the state Nevada
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