FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge HEMO software.
- Recall number
- Z-2341-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge HEMO software.
- Status
- Terminated
- Initiated
- 2012-07-02
- Posted
- 2016-08-04
- Terminated
- 2017-06-26
- Reason
- The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
- Root cause
- Software design
- Action
- The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.
- Quantity
- 37
- Distribution
- The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
- Lot, serial or model codes
- Software versions 8.10, 9.10, 9.20.
- 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