Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations
Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.
What this means for you
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 device software defect that leads to incorrect clinical risk calculations (Gail Risk) for breast cancer. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Unity software, formerly known as DR Systems Unity PACS software. The recall affects software versions 10.0.6 and 10.0.7 that include a license for Mammo Tracking. This medical image and information management system is used to view, process, and manage medical images from diagnostic imaging systems.
The recall is being issued because the software is not identifying patients as having atypical hyperplasia. This failure results in an incorrect Gail Risk calculation, which is a statistical model used to estimate a woman's risk of developing breast cancer. The software is distributed nationwide to sites in California, Kentucky, Maine, Ohio, Oregon, Tennessee, Texas, Washington, and West Virginia.
Eleven sites have potentially affected software. Only customers using versions 10.0.6 or 10.0.7 with a Mammo Tracking license are impacted. Healthcare providers should contact Merge Healthcare for instructions on how to resolve the issue and ensure accurate risk assessments for their patients.
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 m
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 11
Distribution
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