Recall Z-1002-2013— Vital Images, Inc.

Name: FDA recall Z-1002-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-05

Class II · Terminated

Class II FDA medical device recall by Vital Images, Inc., initiated 2013-02-05, terminated 2015-05-08. It names 2 FDA 510(k) clearances: K062154, K002519. Product: Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.. Reason: Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia.

Recalling firm: Vital Images, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Terminated: 2015-05-08
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K062154 — VITAL CONNECT 4.0Vital Images, Inc.·cleared 2006-08-10
K002519 — VITREA 2, VERSION 2.1Vital Images, Inc.·cleared 2000-10-19

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

Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.

Reason for recall

Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia

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