Merge Unity software recall: Software Issue
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…
Why was Merge Unity software recalled?
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 11 sites have potentially affected software
- Distribution
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)