FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: DR Systems Unity PACS software, now known as Merge Unity PACS
- Recall number
- Z-1426-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS
- Status
- Terminated
- Initiated
- 2016-04-08
- Posted
- 2017-03-09
- Terminated
- 2017-03-17
- Reason
- Reports were missing demographic header information when they were faxed to referring physicians.
- Root cause
- Software design
- Action
- Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016, to all affected customers via email on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 8, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. The recalling firm reported emails will be tracked for delivery confirmation. For further questions please call ( 877) 741-5369.
- Quantity
- 9 sites potentially have the affected version
- Distribution
- US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
- 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