FDAFDA · Food and drugs·Recall number Z-2566-2018
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.
Published August 8, 2018 · Recall initiated: August 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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