Vital Images Recalls Vitrea Software Due to Measurement Errors
Vital Images is recalling Vitrea software versions prior to 6.3.3 due to a potential error in measurements generated when images are rotated during reconstruction.
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 involves a medical diagnostic software defect that could lead to incorrect measurements, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Vital Images, Inc. is recalling Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect), and Vitrea fX software. The recall affects all versions prior to 6.3.3, with the exception of versions 6.1.6, 6.2.3, and 6.3. The software is a medical diagnostic system used for the processing, review, analysis, and communication of multidimensional digital images from various imaging devices.
The recall was initiated because Vital Images identified a potential error in measurements generated by the software. This error occurs specifically when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane. The affected units were distributed worldwide, including all states in the continental USA, DC, Puerto Rico, and numerous countries across multiple continents.
Healthcare facilities and users of the affected software versions should check their installed version numbers against the recall criteria. Users should contact Vital Images for instructions on how to update the software to a corrected version or take other necessary actions to mitigate the measurement errors.
The recalled product
- Product
- Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of…
- Manufacturer
- Vital Images, Inc.
Distribution
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