Recall Z-0169-2014 ยท LLZ System, Image Processing, Radiological
Vital Images, Inc.
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,
| Date | Nov 6, 2013 (initiated Oct 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 fieldnotices@vitalimages.com or fax to 1-952-540-3717), and Actions Being Taken by Vital Images (Vital Images Contact Information: I |
| Quantity | 598 |
| Distribution | Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, |
| FDA record | Open on fda.gov |