Agency classClass IIOur severity:High FDA (Devices)·Z-0186-2013·Announced 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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical diagnostic software where potential errors in calcium score values could lead to incorrect clinical assessments. This fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Vital Images, Inc. is recalling software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES). The recall covers specific model numbers and versions, including Vitrea 5.2, 6.0, 6.1, and 6.2; Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2; and Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2, as well as all updates to these versions.

The recall was initiated because Vital Images identified two potential errors in calcium score values. These errors occur in restored snapshots of studies generated through the use of the affected software. The software is a medical diagnostic system used for processing, reviewing, and analyzing multi-dimensional digital images from various imaging devices.

A total of 2,088 units are affected, with 1,133 units distributed in the United States. The remaining units were distributed worldwide to numerous countries. Users of the affected software versions should contact Vital Images for further instructions regarding the recall.

The recalled product

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…
Manufacturer: Vital Images, Inc.
Category: Medical Device — Diagnostic Software
Hazard: mis-labeling
incorrect-data

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Model Number Vitrea 5.2
6.0
6.1
and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1
5.2
and 6.2.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Vital Images, Inc.

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Same hazard · mis labeling