Device 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 media interchange of medical images from a variety of diagnostic imaging systems.
Z-2566-2018
Product summary
- Event
- Event 80570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 sites have potentially affected software
- Official record key
device-enforcement:Z-2566-2018
Official wording
Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Code information: 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.
Distribution pattern: Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Derived failure modes
-
Unknown
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.