FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
- Recall number
- Z-0664-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
- Status
- Terminated
- Initiated
- 2016-01-30
- Posted
- not on file
- Terminated
- 2019-03-20
- Reason
- Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.
- Root cause
- Software design
- Action
- The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016.
- Quantity
- 324 sites potentially have the affected version
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Version 1.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- 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