Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vitrea¿ CT Brain Perfusion made available in various configurations under Recalled by Vital Images, Inc. Due to Vital Images, Inc. (Vital Images) received one report...
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 Vital Images, Inc. directly.
Affected Products
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Quantity: 1,978
Why Was This Recalled?
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
Where Was This Sold?
This product was distributed to 3 states: RI, SD, DC
About Vital Images, Inc.
Vital Images, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report