Agency classClass IIOur severity:High FDA (Devices)·Z-3105-2017·Announced 2017-09-13

Merge Unity Software Recall for Incorrect Gail Risk Calculations

Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.

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 is classified as FDA Class II. The hazard involves a software defect that leads to incorrect risk calculations for breast cancer, which is a significant health risk, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge Unity software, formerly known as DR Systems Unity PACS software. The recall affects software versions 10.0 through 11.1.2 Patch 4 that include a license for Mammo Tracking. The software is a medical image and information management system used for viewing, processing, and managing medical images from diagnostic imaging systems.

The recall is being issued because the software is not identifying the patient as having atypical hyperplasia. This failure results in an incorrect Gail Risk calculation. The Gail Risk model is used to estimate a woman's risk of developing invasive breast cancer.

Nationwide, 98 sites have the potentially affected software. Only customers with one of the listed software versions and a license for Mammo Tracking are impacted by this recall. Users should contact Merge Healthcare for instructions on how to resolve the issue.

The recalled product

Product: Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: software-defect
incorrect-risk-calculation
Affected units: 98

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 (20)

Software versions 10.0
10.0.1
10.0.2
10.0.3
10.0.4
10.0.5
11.0
11.0.1
11.0.2
11.0.3
11.0.4
11.1
11.1.1
11.1.1.1
11.1.1 Patch 2
11.1.1 Patch 3
11.1.2
11.1.2 Patch 1
11.1.2 Patch 2
11.1.2 Patch 3

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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