The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1144-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a data accuracy defect without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary correction.

Plain-English summary

Vital Images, Inc. is performing a field correction on the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. This software provides tools for analyzing clinical CT images of the coronary arteries, heart, and surrounding tissue. The recall affects versions 5.2 through 6.4 of the Vitrea workstation and related suites.

The defect involves the potential for numerical values to be incorrect in the 'Results Table' under the 'Cardiac Analysis' portion of the user interface. Vital Images identified this issue and initiated the field correction to address the data accuracy problem.

The affected units were distributed worldwide, including in the United States and various international locations. Users of the affected software versions should contact Vital Images for information regarding the field correction.

The recalled product

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…
Manufacturer
Vital Images, Inc.
Category
Medical Device — Software
Hazard
Affected units
102

Distribution

Distributed in 16 states:

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