FDA-Device2013-11-13Class II

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 Inte

Vital Images, Inc.
Hazard

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.

Sold states
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, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.
Affected count
598
Manufactured in
5850 Opus Pkwy Ste 300, N/A, Minnetonka, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0169-2014

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