Company:Images, Inc.,
Date of Enforcement Report 2/9/2011
Class ll:
PRODUCT
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient’s coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Recall # Z-1021-2011.
REASON
There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data has moved a distance equivalent to the size of the larger PET data. Therefore, while panning, until the PET image moves, the visual representation of PET will not align accurately with the CT data and the fused PET/CT image may not appear in its correct location.
RECALLING FIRM/MANUFACTURER
Images, Inc., Plymouth, MN, by letter dated August 23, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide and Internationally
