Recall Z-0169-2014— Vital Images, Inc.

Name: FDA recall Z-0169-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-21

Class II · Terminated

Class II FDA medical device recall by Vital Images, Inc., initiated 2013-10-21, terminated 2015-01-16. It names 2 FDA 510(k) clearances: K071362, K062154. Product: 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.. 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..

Recalling firm: Vital Images, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-21
Terminated: 2015-01-16
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K071362 — VITAL CONNECT 4.1Vital Images, Inc.·cleared 2007-05-30
K062154 — VITAL CONNECT 4.0Vital Images, Inc.·cleared 2006-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.