Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00 Recalled by Toshiba American Medical Systems Inc Due to During a procedure the Peak Skin Dose (PSD)...
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
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Quantity: 23
Why Was This Recalled?
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
Where Was This Sold?
This product was distributed to 11 states: AZ, CA, DE, FL, GA, IL, MA, MO, NY, NC, TX
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