Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion
Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the defect may result in patient treatment delays, misdiagnosis, or mistreatment, which constitutes a risk of harm without reported injuries.
Plain-English summary
Vital Images, Inc. is recalling Vitrea CT Brain Perfusion software, available in various configurations including Vitrea, Vitrea fX, VitreaAdvanced, and Vitrea Enterprise Suite. The recall affects versions 6.0 and above. This noninvasive post-processing application is designed to evaluate areas of brain perfusion.
The recall was initiated after Vital Images received one report of potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D. This confusion occurred when the scan was performed using a wide coverage shuttle acquisition technique. The company states that this issue may result in patient treatment delays, misdiagnosis, or mistreatment.
The affected software was distributed worldwide, including the United States (excluding Rhode Island and South Dakota, and including DC and Puerto Rico) and numerous international countries. Vital Images has identified 1,978 units affected by this recall. Users should contact Vital Images for further instructions on how to address this software issue.
The recalled product
- Product
- 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.
- Manufacturer
- Vital Images, Inc.
- Category
- Medical Device — Software
- Affected units
- 1,978
Distribution
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