VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is 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. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.

Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.

Vita Images, Inc. sent an Urgent Medical Device Recall letter on October 21, 2013, to all affected customers via USPS First class mail. The letter described the Reason for Voluntary Recall (Nature of software issue, Potential scenarios which exhibit the issue), Risk to Health (How to confirm if the Snapshots are correct), Actions to be Taken by Customer (Recommended Next Steps which includes to complete and sign the enclosed Effectiveness Check Form and send to [email protected] or fax to 1-952-540-3717), and Actions Being Taken by Vital Images (Vital Images Contact Information: If you have questions, direct Vital Images customers and customers of Toshiba America Medical Systems (TAMS) should contact Vital Images Customer Support at +1-800-208-3005, or by e-mail to [email protected]; customers through a distributor will be contacted by that distributor). For questions regarding this recall call 952-487-9574.