FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: 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.
- Recall number
- Z-2566-2018
- Recalling firm
- Merge Healthcare, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2017-08-07
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 11 sites have potentially affected software
- Distribution
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041935","K143318"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28