FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Hemo, Software packages 10.2, 10.3, and 10.4
- Recall number
- Z-2387-2021
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Hemo, Software packages 10.2, 10.3, and 10.4
- Status
- Terminated
- Initiated
- 2021-07-23
- Posted
- not on file
- Terminated
- 2023-08-29
- Reason
- The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
- Root cause
- Under Investigation by firm
- Action
- The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made.
- Quantity
- 326 units
- Distribution
- US distribution
- Lot, serial or model codes
- Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428
- 510(k) numbers
- ["K152864"]
- 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