CompanyVital Images, Inc. .
Date of Enforcement Report 4/3/2013
Class ll:
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 multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
Recall Number Z-1002-2013
REASON
Vital Images has found a potential error in measurement generated through the software which affects all versions of 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. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. We have found this orientation adjustment to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty-nine percent and in volume measurements of up to fifty percent, so please use caution when reviewing measurements of images reconstructed with orientations that are adjusted in such a manner. This issue was found through internal testing. No customer reports of the issue have been received.
RECALLING FIRM/MANUFACTURER
Vital Images, Inc. Minnetonka, MN, on 2/5/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7649
DISTRIBUTION
Nationwide and Internationally
___________________________________
