The Recall Desk

Manufacturer

Vital Images, Inc.

5 recalls in our database name Vital Images, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2013-11-13

Of the 5 recalls from Vital Images, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-0169-2014·2013-11-13

    Vital Images Recalls VitreaCore Software Due to Image Orientation Defect

    Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.

    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,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2013·2013-05-08

    Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion

    Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.

    Product
    Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1144-2013·2013-04-24

    Vital Images Recalls Vitrea CT Cardiac Analysis Software Due to Data Errors

    Vital Images is correcting a defect in the Vitrea CT Multi-Chamber Cardiac Functional Analysis application where numerical values in the Results Table may be incorrect.

    Product
    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Cham
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1002-2013·2013-04-03

    Vital Images Recalls Vitrea Software Due to Measurement Errors

    Vital Images is recalling Vitrea software versions prior to 6.3.3 due to a potential error in measurements generated when images are rotated during reconstruction.

    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 mult
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0186-2013·2012-11-07

    Vital Images Recalls Vitrea Software Due to Calcium Score Errors

    Vital Images is recalling Vitrea software versions due to potential errors in calcium score values within restored study snapshots.

    Product
    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea En
    Category
    Medical Device
    Distribution
    Distributed nationwide