Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System Recalled by Toshiba American Medical Systems Inc Due to It was found that during a procedure 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
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Quantity: US - 70 systems
Why Was This Recalled?
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
Where Was This Sold?
This product was distributed to 28 states: AL, AR, CA, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, TN, TX, VA, WA
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