FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
- Recall number
- Z-1457-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- not on file
- Terminated
- 2019-08-05
- Reason
- In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
- Root cause
- Software design
- Action
- The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to recall@merge.com.
- Quantity
- 361 sites potentially have the affected versions
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3
- 510(k) numbers
- ["K082421"]
- PMA numbers
- not on file
- Product code
- DQK
- 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