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.
This recall has been terminated (originally issued August 7, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- August 7, 2017
- Terminated
- May 18, 2020
- Recall Number
- Z-2566-2018
- Quantity
- 11 sites have potentially affected software
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Distribution
Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Lot / Code Info
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.
Root Cause
Process design
Action Taken
MERGE sent a Medical Device Recall letter on about 08/07/2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-912-3514.