FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Recall number
- Z-0939-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Status
- Terminated
- Initiated
- 2015-10-15
- Posted
- not on file
- Terminated
- 2021-04-23
- Reason
- The software fails to associate to the correct MG image if there are two images for the same view.
- Root cause
- Software design
- Action
- Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369
- Quantity
- 9 sites potentially have the effected software
- Distribution
- Distribution was made to medical facilities located in MT, CA, PA, and TX.
- Lot, serial or model codes
- Version 11.0
- 510(k) numbers
- ["K041935"]
- 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