FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
- Recall number
- Z-1091-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
- Status
- Terminated
- Initiated
- 2016-03-28
- Posted
- not on file
- Terminated
- 2019-06-28
- Reason
- There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
- Root cause
- Software design
- Action
- MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to reply using the enclosed form and ensure all users of the product are provided with the notification. Customers with questions were instructed to send an email to recall@merge.com..
- Quantity
- 242 sites potentially have the affected versions
- Distribution
- 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