Reported Aug 8, 2018 · Terminated
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- 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 media interchange of medical images from a variety of diagnostic imaging systems.
- Lot codes and dates
- Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.
- Amount recalled
- 11 sites have potentially affected software
Where it was sold
Why it was recalled
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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