Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems Recalled by Toshiba American Medical Systems Inc Due to When a fontal DA (Digital Angiography) acquisition was...
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
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Quantity: 4
Why Was This Recalled?
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
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